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 1 of 21 · 402 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
gabapentin	GABAPENTIN	REMEDYREPACK INC.	4a975ebe-ae0a-446a-8a3d-2ca325e28f93	2026-09-11	Warnings, Adverse reactions	Name fallback brand name: gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	167d8b87-506c-4293-9579-563feaa71583	2026-09-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Clinical Solutions Wholesale, LLC	b7f9a106-52c6-49e4-acf5-8fb07761ba4f	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	d35cd5ac-5ed6-2405-e053-2995a90a6946	2026-09-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	PHOENIX RX LLC	5a85ea98-4211-54eb-e063-6294a90aff33	2026-09-02	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	3dac0d5f-6e65-4c58-9d2a-4f6910b2d4ef	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	REMEDYREPACK INC.	1373587e-807a-462a-bff6-8a7113ce9f0a	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	78445dbf-c7cd-419f-a7be-72821e496628	2026-08-28	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	4615aaa7-73d4-4473-8f26-e7a982f8a166	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	1af098ad-28b5-463f-8efa-24d70a77d64c	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	9a2658d5-9b0e-4921-b4c5-4c89f1630d69	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	43cbff48-8219-41ba-b67d-3ae4544b78bb	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	4c22c3e6-2471-4b89-945b-f846c4d7884e	2026-08-25	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	d06380d0-c894-427e-b13e-5a8f9eb86a34	2026-08-21	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	7652adc6-1aad-4422-b85c-0c6b11c23b73	2026-08-21	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	f0e7a6c9-ae6c-4259-81ab-a37db54e3c80	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
gabapentin	GABAPENTIN	NuCare Pharmaceuticals, Inc.	596eb696-7696-202e-e063-6394a90a2844	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	eb2f6784-e7be-41b6-871b-2c3c961664ab	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	8a781649-3271-47a6-995f-50f91141a48a	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	6670a64f-7f58-479f-b285-394abb753e2e	2026-08-19	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