Application 218491

Type: ANDA
Sponsor: SCIEGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GABAPENTIN	GABAPENTIN	TABLET;ORAL	300MG	No	No
002	GABAPENTIN	GABAPENTIN	TABLET;ORAL	600MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A218491-001	GABAPENTIN	GABAPENTIN	300MG	TABLET / ORAL	AB2		2025-09-19
A218491-002	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB2		2025-09-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A218491-001	AB2
A218491-002	AB2

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A218491-001	GABAPENTIN	300MG	TABLET / ORAL	AB2	2025-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218491-002	GABAPENTIN	600MG	TABLET / ORAL	AB2	2025-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218491-001	GABAPENTIN	300MG	TABLET / ORAL	AB2	2025-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218491-002	GABAPENTIN	600MG	TABLET / ORAL	AB2	2025-09-19	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218491-001	GABAPENTIN	300MG	TABLET / ORAL	AB2	2025-09-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218491-002	GABAPENTIN	600MG	TABLET / ORAL	AB2	2025-09-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A218491-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218491-002	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218491-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218491-002	AB2	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218491-001	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218491-002	AB2	1	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
gabapentin	GABAPENTIN	ScieGen Pharmaceuticals, Inc.	3f2e3ac5-5233-fd57-e063-6294a90a849e	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218491 application number: ANDA218491