Application 202764

Type: ANDA
Sponsor: INVAGEN PHARMS

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 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
A202764-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL			2012-10-16
A202764-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL			2012-10-16

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 · 82 observed 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	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202764-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2012-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202764-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2012-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202764-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2012-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202764-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2012-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202764-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2012-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202764-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2012-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202764-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2012-10-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202764-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2012-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202764-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2012-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202764-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2012-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202764-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2012-10-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202764-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2012-10-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202764-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202764-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202764-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202764-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202764-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202764-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202764-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202764-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202764-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202764-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202764-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202764-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202764-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202764-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202764-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202764-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202764-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202764-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202764-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202764-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202764-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202764-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202764-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202764-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202764-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202764-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202764-001	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202764-002	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202764-001	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202764-002	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202764-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202764-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202764-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202764-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202764-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202764-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202764-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202764-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202764-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202764-002	AB	1	`3f0d92c62455…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	Exelan Pharmaceuticals Inc.	323dad14-ded9-4432-a265-c957e46cc6db	2023-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202764 application number: ANDA202764 ndc (product): 76282-405 ndc (product): 76282-406
Gabapentin	GABAPENTIN	Cipla USA Inc.	7c3ac86f-b8f7-42bf-942a-db854d946e54	2023-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202764 application number: ANDA202764 ndc (product): 69097-811 ndc (product): 69097-812
Gabapentin	GABAPENTIN	Proficient Rx LP	f6baeb5c-ca9c-4730-aeb8-8f8732e8ca3a	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202764 application number: ANDA202764 ndc (product): 63187-785

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 59 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-5562	GABAPENTIN	gabapentin	Liberty Pharmaceuticals, Inc.	ANDA	Current
0440-5563	GABAPENTIN	gabapentin	Liberty Pharmaceuticals, Inc.	ANDA	Current
31722-405	Gabapentin	Gabapentin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-406	Gabapentin	Gabapentin	Camber Pharmaceuticals, Inc.	ANDA	Current
33358-154	Gabapentin	Gabapentin	RxChange Co.	ANDA	Current
43353-190	GABAPENTIN	gabapentin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-190	GABAPENTIN	gabapentin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-190	GABAPENTIN	gabapentin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-190	GABAPENTIN	gabapentin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-872	GABAPENTIN	gabapentin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-872	GABAPENTIN	gabapentin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-872	GABAPENTIN	gabapentin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-872	GABAPENTIN	gabapentin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50268-351	GABAPENTIN	gabapentin	AvPAK	ANDA	Current
50268-351	GABAPENTIN	gabapentin	AvPAK	ANDA	Current
50268-351	GABAPENTIN	gabapentin	AvPAK	ANDA	Current
50268-351	GABAPENTIN	gabapentin	AvPAK	ANDA	Current
50268-352	GABAPENTIN	gabapentin	AvPAK	ANDA	Current
50268-352	GABAPENTIN	gabapentin	AvPAK	ANDA	Current
50268-352	GABAPENTIN	gabapentin	AvPAK	ANDA	Current
52125-816	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
53217-243	Gabapentin	Gabapentin	Aidarex Pharmaceuticals LLC	ANDA	Current
61919-563	GABAPENTIN	GABAPENTIN	DIRECT RX	ANDA	Current
61919-843	GABAPENTIN	GABAPENTIN	DirectRX	ANDA	Current
61919-843	GABAPENTIN	GABAPENTIN	DirectRX	ANDA	Current
63187-149	Gabapentin	Gabapentin	Proficient Rx LP	ANDA	Current
63187-149	Gabapentin	Gabapentin	Proficient Rx LP	ANDA	Current
63187-149	Gabapentin	Gabapentin	Proficient Rx LP	ANDA	Current
63187-231	Gabapentin	Gabapentin	Proficient Rx LP	ANDA	Current
63187-231	Gabapentin	Gabapentin	Proficient Rx LP	ANDA	Current
63187-231	Gabapentin	Gabapentin	Proficient Rx LP	ANDA	Current
63187-785	Gabapentin	Gabapentin	Proficient Rx LP	ANDA	Current
63187-785	Gabapentin	Gabapentin	Proficient Rx LP	ANDA	Current
67046-234	Gabapentin	Gabapentin	Contract Pharmacy Services-PA	ANDA	Current
67046-238	Gabapentin	Gabapentin	Contract Pharmacy Services-PA	ANDA	Current
68788-6336	Gabapentin	Gabapentin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6336	Gabapentin	Gabapentin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7049	Gabapentin	Gabapentin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7049	Gabapentin	Gabapentin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9299	Gabapentin	Gabapentin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9486	Gabapentin	Gabapentin	Preferred Pharmaceuticals, Inc.	ANDA	Current
69097-811	Gabapentin	Gabapentin	Cipla USA Inc.	ANDA	Current
69097-811	Gabapentin	Gabapentin	Cipla USA Inc.	ANDA	Current
69097-811	Gabapentin	Gabapentin	Cipla USA Inc.	ANDA	Current
69097-812	Gabapentin	Gabapentin	Cipla USA Inc.	ANDA	Current
69097-812	Gabapentin	Gabapentin	Cipla USA Inc.	ANDA	Current
69097-812	Gabapentin	Gabapentin	Cipla USA Inc.	ANDA	Current
70518-0483	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-0483	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-0483	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-0483	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-0781	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-0781	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
76282-405	GABAPENTIN	gabapentin	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-405	GABAPENTIN	gabapentin	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-405	GABAPENTIN	gabapentin	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-406	GABAPENTIN	gabapentin	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-406	GABAPENTIN	gabapentin	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-406	GABAPENTIN	gabapentin	Exelan Pharmaceuticals Inc.	ANDA	Current