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BYSANTI

Milsaperidone · Kit

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
BYSANTI
Generic name
Milsaperidone
Dosage form
Kit
Route
Oral
Marketing category
NDA · NDA
Labeler
Vanda Pharmaceuticals Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
6
Packages
6
Data completeness
60% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
Oral
Presentations
12

Regulatory status

Source: Drugs@FDANDC Directory
Application number
220358
Application type
NDA · New Drug Application
Approval date
February 20, 2026
Sponsor
VANDA PHARMS INC
Products on application
7
Submissions recorded
1
Products approved under application 220358.
Product Trade name Form Strength Ingredient Status TE Flags
220358-001 BYSANTI TABLET MILSAPERIDONE Prescription — RLD RS
220358-002 BYSANTI TABLET MILSAPERIDONE Prescription — RLD
220358-003 BYSANTI TABLET MILSAPERIDONE Prescription — RLD
220358-004 BYSANTI TABLET MILSAPERIDONE Prescription — RLD
220358-005 BYSANTI TABLET MILSAPERIDONE Prescription — RLD
220358-006 BYSANTI TABLET MILSAPERIDONE Prescription — RLD
220358-007 BYSANTI TABLET MILSAPERIDONE Prescription — RLD

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
10570453 March 28, 2028 001 No U-4436 March 23, 2026
10570453 March 28, 2028 001 No U-4437 March 23, 2026
10570453 March 28, 2028 002 No U-4437 March 23, 2026
10570453 March 28, 2028 002 No U-4436 March 23, 2026
10570453 March 28, 2028 003 No U-4437 March 23, 2026
10570453 March 28, 2028 003 No U-4436 March 23, 2026
10570453 March 28, 2028 004 No U-4437 March 23, 2026
10570453 March 28, 2028 004 No U-4436 March 23, 2026
10570453 March 28, 2028 005 No U-4437 March 23, 2026
10570453 March 28, 2028 005 No U-4436 March 23, 2026
10570453 March 28, 2028 006 No U-4437 March 23, 2026
10570453 March 28, 2028 006 No U-4436 March 23, 2026
10570453 March 28, 2028 007 No U-4437 March 23, 2026
10570453 March 28, 2028 007 No U-4436 March 23, 2026
9157121 April 5, 2030 001 No U-4436 March 23, 2026
9157121 April 5, 2030 001 No U-4437 March 23, 2026
9157121 April 5, 2030 002 No U-4437 March 23, 2026
9157121 April 5, 2030 002 No U-4436 March 23, 2026
9157121 April 5, 2030 003 No U-4437 March 23, 2026
9157121 April 5, 2030 003 No U-4436 March 23, 2026
9157121 April 5, 2030 004 No U-4437 March 23, 2026
9157121 April 5, 2030 004 No U-4436 March 23, 2026
9157121 April 5, 2030 005 No U-4437 March 23, 2026
9157121 April 5, 2030 005 No U-4436 March 23, 2026
9157121 April 5, 2030 006 No U-4437 March 23, 2026
9157121 April 5, 2030 006 No U-4436 March 23, 2026
9157121 April 5, 2030 007 No U-4437 March 23, 2026
9157121 April 5, 2030 007 No U-4436 March 23, 2026
10563259 July 24, 2030 001 No U-4436 March 23, 2026
10563259 July 24, 2030 001 No U-4437 March 23, 2026
10563259 July 24, 2030 002 No U-4436 March 23, 2026
10563259 July 24, 2030 002 No U-4437 March 23, 2026
10563259 July 24, 2030 003 No U-4436 March 23, 2026
10563259 July 24, 2030 003 No U-4437 March 23, 2026
10563259 July 24, 2030 004 No U-4436 March 23, 2026
10563259 July 24, 2030 004 No U-4437 March 23, 2026
10563259 July 24, 2030 005 No U-4436 March 23, 2026
10563259 July 24, 2030 005 No U-4437 March 23, 2026
10563259 July 24, 2030 006 No U-4437 March 23, 2026
10563259 July 24, 2030 006 No U-4436 March 23, 2026
10563259 July 24, 2030 007 No U-4437 March 23, 2026
10563259 July 24, 2030 007 No U-4436 March 23, 2026
12606869 September 22, 2030 001 No U-4506 May 21, 2026
12606869 September 22, 2030 001 No U-4507 May 21, 2026
12606869 September 22, 2030 002 No U-4506 May 21, 2026
12606869 September 22, 2030 002 No U-4507 May 21, 2026
12606869 September 22, 2030 003 No U-4506 May 21, 2026
12606869 September 22, 2030 003 No U-4507 May 21, 2026
12606869 September 22, 2030 004 No U-4506 May 21, 2026
12606869 September 22, 2030 004 No U-4507 May 21, 2026
12606869 September 22, 2030 005 No U-4506 May 21, 2026
12606869 September 22, 2030 005 No U-4507 May 21, 2026
12606869 September 22, 2030 006 No U-4506 May 21, 2026
12606869 September 22, 2030 006 No U-4507 May 21, 2026
12606869 September 22, 2030 007 No U-4506 May 21, 2026
12606869 September 22, 2030 007 No U-4507 May 21, 2026
8999638 October 28, 2030 001 No U-4436 March 23, 2026
8999638 October 28, 2030 001 No U-4437 March 23, 2026
8999638 October 28, 2030 002 No U-4436 March 23, 2026
8999638 October 28, 2030 002 No U-4437 March 23, 2026
8999638 October 28, 2030 003 No U-4436 March 23, 2026
8999638 October 28, 2030 003 No U-4437 March 23, 2026
8999638 October 28, 2030 004 No U-4436 March 23, 2026
8999638 October 28, 2030 004 No U-4437 March 23, 2026
8999638 October 28, 2030 005 No U-4436 March 23, 2026
8999638 October 28, 2030 005 No U-4437 March 23, 2026
8999638 October 28, 2030 006 No U-4436 March 23, 2026
8999638 October 28, 2030 006 No U-4437 March 23, 2026
8999638 October 28, 2030 007 No U-4436 March 23, 2026
8999638 October 28, 2030 007 No U-4437 March 23, 2026
9074255 December 17, 2030 001 No U-4436 March 23, 2026
9074255 December 17, 2030 001 No U-4437 March 23, 2026
9074255 December 17, 2030 002 No U-4437 March 23, 2026
9074255 December 17, 2030 002 No U-4436 March 23, 2026
9074255 December 17, 2030 003 No U-4437 March 23, 2026
9074255 December 17, 2030 003 No U-4436 March 23, 2026
9074255 December 17, 2030 004 No U-4437 March 23, 2026
9074255 December 17, 2030 004 No U-4436 March 23, 2026
9074255 December 17, 2030 005 No U-4437 March 23, 2026
9074255 December 17, 2030 005 No U-4436 March 23, 2026
9074255 December 17, 2030 006 No U-4437 March 23, 2026
9074255 December 17, 2030 006 No U-4436 March 23, 2026
9074255 December 17, 2030 007 No U-4437 March 23, 2026
9074255 December 17, 2030 007 No U-4436 March 23, 2026
9072742 January 16, 2031 001 No U-4436 March 23, 2026
9072742 January 16, 2031 001 No U-4437 March 23, 2026
9072742 January 16, 2031 002 No U-4436 March 23, 2026
9072742 January 16, 2031 002 No U-4437 March 23, 2026
9072742 January 16, 2031 003 No U-4436 March 23, 2026
9072742 January 16, 2031 003 No U-4437 March 23, 2026
9072742 January 16, 2031 004 No U-4436 March 23, 2026
9072742 January 16, 2031 004 No U-4437 March 23, 2026
9072742 January 16, 2031 005 No U-4436 March 23, 2026
9072742 January 16, 2031 005 No U-4437 March 23, 2026
9072742 January 16, 2031 006 No U-4436 March 23, 2026
9072742 January 16, 2031 006 No U-4437 March 23, 2026
9072742 January 16, 2031 007 No U-4436 March 23, 2026
9072742 January 16, 2031 007 No U-4437 March 23, 2026
9074256 February 10, 2031 001 No U-4436 March 23, 2026
9074256 February 10, 2031 001 No U-4437 March 23, 2026
9074256 February 10, 2031 002 No U-4436 March 23, 2026
9074256 February 10, 2031 002 No U-4437 March 23, 2026
9074256 February 10, 2031 003 No U-4436 March 23, 2026
9074256 February 10, 2031 003 No U-4437 March 23, 2026
9074256 February 10, 2031 004 No U-4436 March 23, 2026
9074256 February 10, 2031 004 No U-4437 March 23, 2026
9074256 February 10, 2031 005 No U-4437 March 23, 2026
9074256 February 10, 2031 005 No U-4436 March 23, 2026
9074256 February 10, 2031 006 No U-4437 March 23, 2026
9074256 February 10, 2031 006 No U-4436 March 23, 2026
9074256 February 10, 2031 007 No U-4437 March 23, 2026
9074256 February 10, 2031 007 No U-4436 March 23, 2026
9074254 December 28, 2031 001 No U-4436 March 23, 2026
9074254 December 28, 2031 001 No U-4437 March 23, 2026
9074254 December 28, 2031 002 No U-4437 March 23, 2026
9074254 December 28, 2031 002 No U-4436 March 23, 2026
9074254 December 28, 2031 003 No U-4437 March 23, 2026
9074254 December 28, 2031 003 No U-4436 March 23, 2026
9074254 December 28, 2031 004 No U-4437 March 23, 2026
9074254 December 28, 2031 004 No U-4436 March 23, 2026
9074254 December 28, 2031 005 No U-4437 March 23, 2026
9074254 December 28, 2031 005 No U-4436 March 23, 2026
9074254 December 28, 2031 006 No U-4437 March 23, 2026
9074254 December 28, 2031 006 No U-4436 March 23, 2026
9074254 December 28, 2031 007 No U-4437 March 23, 2026
9074254 December 28, 2031 007 No U-4436 March 23, 2026
12478619 May 31, 2044 001 No U-4434 March 23, 2026
12478619 May 31, 2044 001 No U-4435 March 23, 2026
12478619 May 31, 2044 002 No U-4435 March 23, 2026
12478619 May 31, 2044 002 No U-4434 March 23, 2026
12478619 May 31, 2044 003 No U-4435 March 23, 2026
12478619 May 31, 2044 003 No U-4434 March 23, 2026
12478619 May 31, 2044 004 No U-4435 March 23, 2026
12478619 May 31, 2044 004 No U-4434 March 23, 2026
12478619 May 31, 2044 005 No U-4435 March 23, 2026
12478619 May 31, 2044 005 No U-4434 March 23, 2026
12478619 May 31, 2044 006 No U-4435 March 23, 2026
12478619 May 31, 2044 006 No U-4434 March 23, 2026
12478619 May 31, 2044 007 No U-4435 March 23, 2026
12478619 May 31, 2044 007 No U-4434 March 23, 2026
Regulatory exclusivity periods.
Code Expires Product
NCE February 20, 2031 001
NCE February 20, 2031 002
NCE February 20, 2031 003
NCE February 20, 2031 004
NCE February 20, 2031 005
NCE February 20, 2031 006
NCE February 20, 2031 007

Approval history

Source: Drugs@FDA
Most recent submissions on application 220358.
Type No. Action Status Date Review
Original application 1 Type 1 - New Molecular Entity Approved February 20, 2026 Standard

Review documents

  • 0 · Original application · March 10, 2026
  • 0 · Original application · March 10, 2026
  • 0 · Original application · February 25, 2026
  • 0 · Original application · February 24, 2026

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
43068-713-04 43068-713 Vanda Pharmaceuticals Inc. 2 CARTON in 1 BLISTER PACK (43068-713-04) / 1 KIT in 1 CARTON July 1, 2026
43068-714-04 43068-714 Vanda Pharmaceuticals Inc. 4 CARTON in 1 BLISTER PACK (43068-714-04) / 1 KIT in 1 CARTON July 1, 2026
43068-715-03 43068-715 Vanda Pharmaceuticals Inc. 6 CARTON in 1 BLISTER PACK (43068-715-03) / 1 KIT in 1 CARTON July 1, 2026
43068-912-08 43068-912 Vanda Pharmaceuticals Inc. 2 CARTON in 1 BLISTER PACK (43068-912-08) / 1 KIT in 1 CARTON July 1, 2026
43068-913-12 43068-913 Vanda Pharmaceuticals Inc. 4 CARTON in 1 BLISTER PACK (43068-913-12) / 1 KIT in 1 CARTON July 1, 2026
43068-914-08 43068-914 Vanda Pharmaceuticals Inc. 6 CARTON in 1 BLISTER PACK (43068-914-08) / 1 KIT in 1 CARTON July 1, 2026
43068-713 43068-713 Vanda Pharmaceuticals Inc. — July 1, 2026
43068-714 43068-714 Vanda Pharmaceuticals Inc. — July 1, 2026
43068-715 43068-715 Vanda Pharmaceuticals Inc. — July 1, 2026
43068-912 43068-912 Vanda Pharmaceuticals Inc. — July 1, 2026
43068-913 43068-913 Vanda Pharmaceuticals Inc. — July 1, 2026
43068-914 43068-914 Vanda Pharmaceuticals Inc. — July 1, 2026

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity

Generated September 25, 2026 · 9 sections on this page.