Application 077242

Type: ANDA
Sponsor: SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GABAPENTIN	GABAPENTIN	CAPSULE;ORAL	100MG	No	No
002	GABAPENTIN	GABAPENTIN	CAPSULE;ORAL	300MG	No	No
003	GABAPENTIN	GABAPENTIN	CAPSULE;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077242-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24
A077242-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24
A077242-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077242-002	GABAPENTIN	300MG	CAPSULE / ORAL	2006-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077242-003	GABAPENTIN	400MG	CAPSULE / ORAL	2006-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077242-001	GABAPENTIN	100MG	CAPSULE / ORAL	2006-08-24	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A077242-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077242-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077242-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077242-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077242-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077242-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077242-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077242-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077242-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077242-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077242-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077242-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077242-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077242-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077242-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077242-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077242-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077242-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077242-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077242-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077242-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077242-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077242-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077242-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077242-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077242-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077242-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077242-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077242-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077242-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077242-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077242-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077242-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077242-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077242-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077242-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077242-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077242-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077242-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077242-001	AB	1	`ea99ee380514…`

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	Sun Pharmaceutical Industries, Inc.	c9a05f0c-b5f0-422c-9d67-6d0efc921a74	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077242 application number: ANDA077242 ndc (product): 62756-139 ndc (product): 62756-138 ndc (product): 62756-137

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45861-111	GABAPENTIN	GABAPENTIN	Pharmaceutica North America, Inc.	ANDA	Current
50090-0895	gabapentin	gabapentin	A-S Medication Solutions	ANDA	Current
50090-0948	gabapentin	gabapentin	A-S Medication Solutions	ANDA	Current
61919-101	GABAPENTIN	GABAPENTIN	Direct Rx	ANDA	Current
61919-102	Gabapentin	Gabapentin	Direct Rx	ANDA	Current
61919-102	GABAPENTIN	GABAPENTIN	Direct Rx	ANDA	Current
61919-492	GABAPENTIN	GABAPENTIN	Direct Rx	ANDA	Current
62756-137	gabapentin	gabapentin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-137	gabapentin	gabapentin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-137	gabapentin	gabapentin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-138	gabapentin	gabapentin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-138	gabapentin	gabapentin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-138	gabapentin	gabapentin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-139	gabapentin	gabapentin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-139	gabapentin	gabapentin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-139	gabapentin	gabapentin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
64725-0138	GABAPENTIN	GABAPENTIN	TYA Pharmaceuticals	ANDA	Current