Application 209306

Type: ANDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GABAPENTIN	GABAPENTIN	TABLET;ORAL	600MG	No	No
002	GABAPENTIN	GABAPENTIN	TABLET;ORAL	800MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A209306-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL			2018-08-24
A209306-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL			2018-08-24

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.

Product history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209306-001	GABAPENTIN	600MG	TABLET / ORAL	2018-08-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209306-002	GABAPENTIN	800MG	TABLET / ORAL	2018-08-24	`4b0b4de00fa7…`

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 12 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	7d3fc163-25f0-2c61-e053-2991aa0a76e9	2025-05-23	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Amneal Pharmaceuticals LLC	772d9e7a-3811-455a-99e6-f2a3d0769b9b	2025-05-13	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aurobindo Pharma Limited	1a619a14-0b63-4cba-80e7-474c9a1c90b9	2025-05-12	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aurobindo Pharma Limited	25cf6c40-a239-4dd0-9cad-28da84d285db	2025-05-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	3c8dca11-78ab-45c1-8bb2-89a41ea5dfa9	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Exelan Pharmaceuticals, Inc.	41d1ead3-046e-4abf-ae0a-cb126a1f5848	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Actavis Pharma, Inc.	5969871e-6c71-4c37-9d63-370718ccc80c	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Cipla USA Inc.	9e4eca9c-6a2c-4ede-a252-1a27094bf594	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Direct_Rx	30a2ed14-dcda-f972-e063-6294a90a417c	2025-04-23	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	McKesson Corporation dba Sky Packaging	23eb133e-2f74-4219-9892-0a8e770ec032	2025-04-17	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Mylan Pharmaceuticals Inc.	cff7de45-148b-4e96-88fd-6052bf75b5f7	2025-04-12	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Westminster Pharmaceuticals, LLC	3ad96553-73a4-4a9b-8a89-10a29b794ed3	2025-04-04	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Proficient Rx LP	7fcce531-bf7c-43b6-bea9-8f0602842c53	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Coupler LLC	3133c863-d33b-c9d7-e063-6294a90ae898	2025-03-25	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Coupler LLC	3133fc78-dd7a-880c-e063-6394a90a89e1	2025-03-25	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Precision Dose, Inc.	86c93d8b-6286-44e2-93dd-f1b10a5d83da	2025-03-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	87b9171b-7d00-40fa-87ff-a717740efe8a	2025-03-02	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	64a65366-8577-48f2-9f8e-0332f126d3c1	2025-03-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	NuCare Pharmaceuticals, Inc.	200b61d7-6e4c-923d-e063-6294a90a42cf	2025-02-21	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	35ac6b11-7b1c-47a0-a4ba-c193a0bb5b01	2025-02-20	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.