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SUBVENITE

Lamotrigine · Kit

Prescription ANDA TE AB
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
SUBVENITE
Generic name
Lamotrigine
Dosage form
Kit
Route
—
Marketing category
ANDA · ANDA
Labeler
OWP Pharmaceuticals, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
3
Packages
3
Data completeness
54% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
—
Presentations
6

Regulatory status

Source: Drugs@FDANDC Directory
Application number
078947
Application type
ANDA · Abbreviated New Drug Application
Approval date
January 27, 2009
Sponsor
TORRENT PHARMS
Products on application
4
Submissions recorded
22
Products approved under application 078947.
Product Trade name Form Strength Ingredient Status TE Flags
078947-001 LAMOTRIGINE TABLET LAMOTRIGINE Prescription AB
078947-002 LAMOTRIGINE TABLET LAMOTRIGINE Prescription AB
078947-003 LAMOTRIGINE TABLET LAMOTRIGINE Prescription AB
078947-004 LAMOTRIGINE TABLET LAMOTRIGINE Prescription AB

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
No
Reference Standard
No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

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

Approval history

Source: Drugs@FDA
Most recent submissions on application 078947.
Type No. Action Status Date Review
Supplement 43 Labeling Approved April 10, 2026 Standard
Supplement 42 Labeling Approved April 10, 2026 Standard
Supplement 41 Labeling Approved April 10, 2026 Standard
Supplement 40 Labeling Approved April 10, 2026 Standard
Supplement 38 Labeling Approved June 30, 2022 Standard
Supplement 37 Labeling Approved June 30, 2022 Standard
Supplement 34 Labeling Approved December 6, 2019 Standard
Supplement 33 Labeling Approved December 6, 2019 Standard
Supplement 32 Labeling Approved December 6, 2019 Standard
Supplement 26 Labeling Approved January 29, 2018 Standard
Supplement 23 Labeling Approved June 16, 2017 Standard
Supplement 22 Labeling Approved June 16, 2017 Standard
Supplement 21 Labeling Approved December 10, 2014 Standard
Supplement 18 Labeling Approved December 10, 2014 Standard
Supplement 15 Labeling Approved March 14, 2012 —
Supplement 14 Labeling Approved January 31, 2012 —
Supplement 11 Labeling Approved September 29, 2011 —
Supplement 9 Labeling Approved July 28, 2010 —
Supplement 8 REMS Approved January 21, 2010 —
Supplement 6 Labeling Approved September 21, 2009 —
Supplement 5 Labeling Approved September 21, 2009 —
Original application 1 Approved January 27, 2009 —

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
69102-300-01 69102-300 OWP Pharmaceuticals, Inc. 7 BLISTER PACK in 1 PACKAGE, COMBINATION (69102-300-01) / 1 KIT in 1 BLISTER PACK April 14, 2018
69102-306-01 69102-306 OWP Pharmaceuticals, Inc. 35 BLISTER PACK in 1 BLISTER PACK (69102-306-01) / 1 KIT in 1 BLISTER PACK April 14, 2018
69102-312-01 69102-312 OWP Pharmaceuticals, Inc. 14 BLISTER PACK in 1 PACKAGE, COMBINATION (69102-312-01) / 1 KIT in 1 BLISTER PACK April 14, 2018
69102-300 69102-300 OWP Pharmaceuticals, Inc. — April 14, 2018
69102-306 69102-306 OWP Pharmaceuticals, Inc. — April 14, 2018
69102-312 69102-312 OWP Pharmaceuticals, Inc. — April 14, 2018

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.