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 17 of 21 · 402 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	Clinical Solutions Wholesale, LLC	934fefae-b895-427c-8798-4c5462b1ecc2	2024-04-11	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	ed219efc-84e3-5bdc-e053-2a95a90a56fc	2024-04-11	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Clinical Solutions Wholesale, LLC	dbedccfb-0e27-4119-93b9-241c039e045a	2024-04-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	47f2a06f-4eac-4dca-aa2a-a36dd4daaea0	2024-04-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	38210141-bbdc-4186-b71f-54c72f794dca	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	75418d32-6504-4cb4-b3a9-afa0eaf19b8d	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	1ec656c9-034f-4f14-9e6b-9779d41e1627	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	8de89818-805a-4a20-a9b1-48cf443b6315	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	9efd0261-9fc9-4dc9-8cf3-9110157ddfc4	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	b4954172-5439-48fd-8348-8a2e0d2fee62	2024-04-02	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	01b810b7-f4c8-4412-bbc5-b9220d8770d8	2024-04-02	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	c9944562-563a-423d-972c-f0313375d234	2024-04-02	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Medsource Pharmaceuticals	12f0c2ee-9a44-9778-e063-6294a90a3b58	2024-03-05	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	1749d731-bc8c-4374-b2a9-7c809c457f56	2024-03-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Medsource Pharmaceuticals	1278512b-1493-db65-e063-6394a90ab161	2024-02-28	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	7a2aa696-7dac-4d03-916a-374b61a255b5	2024-02-16	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	79cd9dea-e7d0-44db-afba-964cb99f32b6	2024-01-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	f9bf87e4-5499-4dd7-a0c1-16025a718d14	2024-01-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	f38098ec-dd1a-405a-bbfb-bad62e4e7fa5	2024-01-04	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	56967a93-b3c0-4043-9241-585fc64e2624	2023-12-20	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.

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