Application 078150

Type: ANDA
Sponsor: HIKMA

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
A078150-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25
A078150-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25
A078150-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25

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	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078150-002	GABAPENTIN	300MG	CAPSULE / ORAL	2007-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078150-003	GABAPENTIN	400MG	CAPSULE / ORAL	2007-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078150-001	GABAPENTIN	100MG	CAPSULE / ORAL	2007-09-25	`301d65b070ca…`

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 3 of 21 · 402 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	ScieGen Pharmaceuticals, Inc.	16542ee6-0e0e-4d3c-8b32-60ff6ef48846	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
gabapentin	GABAPENTIN	REMEDYREPACK INC.	32169228-e85c-4dbf-8722-cd2f8e0f5d1a	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	57492b91-1fe2-74ab-e063-6394a90a0b9e	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	4a95f18e-0de4-4ce1-9f97-bc2e8a5bac6a	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	3c585b71-5cfc-18d6-e063-6294a90a3dcf	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	172776c0-909e-49ce-bfe1-cf154a9458ba	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a1006139-7dfc-4d87-a5a9-aeb380c32d24	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	df9c7c84-a8d9-4da8-babe-c55c9420d4e6	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	6beed8eb-446c-4575-8dc8-b798623d92c7	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	7ddc7d92-9076-41cf-97ed-d9f9edc80298	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	72729513-bd34-44f5-9f62-297ed25c4442	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	f31172a2-0ae9-49f2-b797-b26fe33f3f64	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	6a0a75ac-e121-477b-a9d1-d11f588afc9d	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	b6db5ce9-bd4b-420d-88a7-df9d46144c81	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	9b175f8d-7667-4bfe-8bb5-fd7441eed456	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	4ddcdff5-8f1f-bff3-e063-6294a90a1195	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	HAWAII REPACK, INC.	dd7adad2-e2f5-4b43-90a4-522bce0be5b3	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	HAWAII REPACK, INC.	f6ff265b-569b-4f5c-8fdb-00b7ad4aac7c	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
gabapentin	GABAPENTIN	Sun Pharmaceutical Industries, Inc.	c9a05f0c-b5f0-422c-9d67-6d0efc921a74	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Strides Pharma Science Limited	43b67ae3-ac6f-48f5-8788-9ead08376864	2026-07-02	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-3991	Gabapentin	Gabapentin	West-ward Pharmaceutical Corp	ANDA	Current
0143-3993	Gabapentin	Gabapentin	West-ward Pharmaceutical Corp	ANDA	Current
0143-3994	Gabapentin	Gabapentin	West-ward Pharmaceutical Corp	ANDA	Current
0143-9992	Gabapentin	Gabapentin	West-ward Pharmaceutical Corp	ANDA	Current
0143-9993	Gabapentin	Gabapentin	West-ward Pharmaceutical Corp	ANDA	Current
0143-9994	Gabapentin	Gabapentin	West-ward Pharmaceutical Corp	ANDA	Current
59115-073	Gabapentin	Gabapentin	Hikma Pharmaceutical	ANDA	Current
59115-073	Gabapentin	Gabapentin	Hikma Pharmaceutical	ANDA	Current
59115-074	Gabapentin	Gabapentin	Hikma Pharmaceutical	ANDA	Current
59115-074	Gabapentin	Gabapentin	Hikma Pharmaceutical	ANDA	Current
59115-075	Gabapentin	Gabapentin	Hikma Pharmaceutical	ANDA	Current
59115-075	Gabapentin	Gabapentin	Hikma Pharmaceutical	ANDA	Current
66336-439	Gabapentin	Gabapentin	Dispensing Solutions, Inc.	ANDA	Current
66336-567	Gabapentin	Gabapentin	Dispensing Solutions, Inc.	ANDA	Current