Application 211314

Type: ANDA
Sponsor: STRIDES PHARMA

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 1.

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	TE codes	Approval date
A211314-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16
A211314-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16
A211314-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A211314-001	AB
A211314-002	AB
A211314-003	AB

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 · 123 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	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211314-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2018-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211314-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2018-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211314-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2018-10-16	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211314-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211314-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211314-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211314-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211314-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211314-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211314-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211314-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211314-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211314-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211314-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211314-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211314-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211314-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211314-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211314-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211314-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211314-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211314-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211314-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211314-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211314-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211314-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211314-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211314-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211314-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211314-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211314-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211314-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211314-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211314-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211314-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211314-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211314-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211314-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211314-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211314-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211314-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211314-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211314-001	AB	1	`8072bd15b7f6…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	Strides Pharma Science Limited	43b67ae3-ac6f-48f5-8788-9ead08376864	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211314 application number: ANDA211314 ndc (product): 64380-869 ndc (product): 64380-868 ndc (product): 64380-867
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	4c22c3e6-2471-4b89-945b-f846c4d7884e	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211314 application number: ANDA211314
GABAPENTIN	GABAPENTIN	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	d8daa30f-1cb3-46aa-9b68-d9aa5b0a2105	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211314 application number: ANDA211314
GABAPENTIN	GABAPENTIN	Coupler LLC	2cdbb381-88a2-5c5a-e063-6294a90a3e1e	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211314 application number: ANDA211314

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
64380-867	GABAPENTIN	gabapentin	Strides Pharma Science Limited	ANDA	Current
64380-867	GABAPENTIN	gabapentin	Strides Pharma Science Limited	ANDA	Current
64380-867	GABAPENTIN	gabapentin	Strides Pharma Science Limited	ANDA	Current
64380-867	GABAPENTIN	gabapentin	Strides Pharma Science Limited	ANDA	Current
64380-867	GABAPENTIN	gabapentin	Strides Pharma Science Limited	ANDA	Current
64380-868	GABAPENTIN	gabapentin	Strides Pharma Science Limited	ANDA	Current
64380-868	GABAPENTIN	gabapentin	Strides Pharma Science Limited	ANDA	Current
64380-868	GABAPENTIN	gabapentin	Strides Pharma Science Limited	ANDA	Current
64380-868	GABAPENTIN	gabapentin	Strides Pharma Science Limited	ANDA	Current
64380-868	GABAPENTIN	gabapentin	Strides Pharma Science Limited	ANDA	Current
64380-869	GABAPENTIN	gabapentin	Strides Pharma Science Limited	ANDA	Current
64380-869	GABAPENTIN	gabapentin	Strides Pharma Science Limited	ANDA	Current
64380-869	GABAPENTIN	gabapentin	Strides Pharma Science Limited	ANDA	Current
64380-869	GABAPENTIN	gabapentin	Strides Pharma Science Limited	ANDA	Current
64380-869	GABAPENTIN	gabapentin	Strides Pharma Science Limited	ANDA	Current
70934-621	GABAPENTIN	gabapentin	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-635	GABAPENTIN	gabapentin	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current