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Gattex

teduglutide · 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
Gattex
Generic name
teduglutide
Dosage form
Kit
Route
—
Marketing category
NDA · NDA
Labeler
Takeda Pharmaceuticals America, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
—
Presentations
4

Regulatory status

Source: Drugs@FDANDC Directory
Application number
203441
Application type
NDA · New Drug Application
Approval date
December 21, 2012
Sponsor
TAKEDA PHARMS USA
Products on application
1
Submissions recorded
19
Products approved under application 203441.
Product Trade name Form Strength Ingredient Status TE Flags
203441-001 GATTEX KIT POWDER TEDUGLUTIDE Prescription — RLD RS

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
9060992 November 1, 2025 001 No U-1320 July 17, 2015
7847061 November 1, 2025 001 No U-1320 January 18, 2013
7847061*PED May 1, 2026 001 No —
9060992*PED May 1, 2026 001 No —
Regulatory exclusivity periods.
Code Expires Product
ODE-240 May 16, 2026 001

Approval history

Source: Drugs@FDA
Most recent submissions on application 203441.
Type No. Action Status Date Review
Supplement 28 REMS Approved August 26, 2026 N/A
Supplement 24 Labeling Approved September 5, 2025 Standard
Supplement 23 REMS Approved August 13, 2025 N/A
Supplement 22 Labeling Approved September 19, 2024 Standard
Supplement 21 Manufacturing (CMC) Approved February 21, 2024 N/A
Supplement 16 Labeling Approved January 24, 2023 Standard
Supplement 20 REMS Approved February 11, 2021 N/A
Supplement 18 Labeling Approved January 29, 2021 Standard
Supplement 19 REMS Approved July 14, 2020 N/A
Supplement 13 Efficacy Approved May 16, 2019 Priority
Supplement 12 Efficacy Approved December 18, 2018 Standard
Supplement 10 REMS Approved March 21, 2017 N/A
Supplement 8 REMS Approved May 27, 2016 N/A
Supplement 7 Manufacturing (CMC) Approved March 30, 2016 Standard
Supplement 6 Manufacturing (CMC) Approved October 5, 2015 Standard
Supplement 5 Manufacturing (CMC) Approved May 18, 2015 Standard
Supplement 4 Manufacturing (CMC) Approved January 5, 2015 Standard
Supplement 2 Efficacy Approved June 26, 2014 Standard
Original application 1 Type 1 - New Molecular Entity Approved December 21, 2012 Standard

Review documents

  • 0 · Supplement · August 28, 2026
  • 0 · Supplement · September 9, 2025
  • 0 · Supplement · September 9, 2025
  • 0 · Supplement · September 8, 2025
  • 0 · Supplement · August 15, 2025
  • 0 · Supplement · September 23, 2024
  • 0 · Supplement · February 22, 2024
  • 0 · Supplement · February 22, 2024
  • 0 · Original application · November 6, 2023
  • 0 · Supplement · January 30, 2023
  • 0 · Supplement · January 25, 2023
  • 0 · Supplement · February 16, 2021
  • 0 · Supplement · February 2, 2021
  • 0 · Supplement · February 1, 2021
  • 0 · Supplement · July 20, 2020
  • 0 · Supplement · May 21, 2019
  • 0 · Supplement · May 20, 2019
  • 0 · Supplement · December 21, 2018
  • 0 · Supplement · December 19, 2018
  • 0 · Appl · March 28, 2017
  • 0 · Supplement · March 24, 2017
  • 0 · Supplement · May 31, 2016
  • 0 · Supplement · February 3, 2016
  • 0 · Supplement · June 30, 2014
  • 0 · Supplement · June 27, 2014
  • 0 · Original application · January 25, 2013
  • 0 · Original application · January 25, 2013
  • 0 · Original application · December 27, 2012
  • 0 · Original application · December 27, 2012
  • 0 · Supplement · January 1, 1900

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
68875-0102-1 68875-0102 Takeda Pharmaceuticals America, Inc. 1 KIT in 1 CARTON (68875-0102-1) * .5 mL in 1 SYRINGE, PLASTIC * .7 mL in 1 PACKET * .5 mL in 1 VIAL (68875-0101-1) December 21, 2012
68875-0103-1 68875-0103 Takeda Pharmaceuticals America, Inc. 1 KIT in 1 CARTON (68875-0103-1) * .5 mL in 1 SYRINGE, PLASTIC * .7 mL in 1 PACKET * .5 mL in 1 VIAL (68875-0101-1) December 21, 2012
68875-0102 68875-0102 Takeda Pharmaceuticals America, Inc. — December 21, 2012
68875-0103 68875-0103 Takeda Pharmaceuticals America, Inc. — December 21, 2012

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 · 8 sections on this page.