Application 207099

Type: ANDA
Sponsor: EPIC PHARMA LLC

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
A207099-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24
A207099-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24
A207099-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207099-001	AB
A207099-002	AB
A207099-003	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	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`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	A207099-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207099-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207099-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207099-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207099-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207099-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207099-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207099-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207099-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207099-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207099-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207099-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207099-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207099-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207099-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207099-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207099-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207099-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207099-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207099-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207099-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207099-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207099-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207099-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207099-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207099-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207099-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207099-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207099-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207099-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207099-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207099-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207099-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207099-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207099-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207099-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207099-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207099-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207099-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207099-001	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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
gabapentin	GABAPENTIN	REMEDYREPACK INC.	32169228-e85c-4dbf-8722-cd2f8e0f5d1a	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	2bc65375-77b8-1e50-e063-6294a90acf8f	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
gabapentin	GABAPENTIN	Proficient Rx LP	c7674ea5-276b-4bb3-821b-4ac05c9e64e6	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
Gabapentin	GABAPENTIN	Direct_Rx	0b286fd1-8179-d87a-e063-6294a90a2f23	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
gabapentin	GABAPENTIN	Coupler LLC	47cd25f6-e123-9aaf-e063-6394a90aeedd	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
gabapentin	GABAPENTIN	Northwind Health Company, LLC	471b2d32-0cbd-aade-e063-6394a90a1696	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
gabapentin	GABAPENTIN	REMEDYREPACK INC.	4a975ebe-ae0a-446a-8a3d-2ca325e28f93	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
gabapentin	GABAPENTIN	Coupler LLC	3eeda97d-c3cd-65cd-e063-6394a90aae8b	2025-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
Gabapentin	GABAPENTIN	Direct_Rx	2cb1ad6d-d389-4564-e063-6394a90a3644	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
gabapentin	GABAPENTIN	Rising Pharma Holdings, Inc.	969cccfc-e56a-49da-9d36-47c0c3fad7f8	2025-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099 ndc (product): 16571-869 ndc (product): 16571-867 ndc (product): 16571-868
Gabapentin	GABAPENTIN	Proficient Rx LP	64a65366-8577-48f2-9f8e-0332f126d3c1	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
Gabapentin	GABAPENTIN	Epic Pharma, LLC	030e656a-e384-49ac-830f-32140c18112d	2019-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099 ndc (product): 42806-510 ndc (product): 42806-511 ndc (product): 42806-509

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-867	Gabapentin	Gabapentin	Rising Pharma Holdings, Inc.	ANDA	Current
16571-868	Gabapentin	Gabapentin	Rising Pharma Holdings, Inc.	ANDA	Current
16571-869	Gabapentin	Gabapentin	Rising Pharma Holdings, Inc.	ANDA	Current
42806-509	Gabapentin	Gabapentin	Epic Pharma, LLC	ANDA	Current
42806-510	Gabapentin	Gabapentin	Epic Pharma, LLC	ANDA	Current
42806-511	Gabapentin	Gabapentin	Epic Pharma, LLC	ANDA	Current
58657-720	Gabapentin	Gabapentin	Method Pharmaceuticals, LLC	ANDA	Current
58657-720	Gabapentin	Gabapentin	Method Pharmaceuticals, LLC	ANDA	Current
58657-721	Gabapentin	Gabapentin	Method Pharmaceuticals, LLC	ANDA	Current
58657-721	Gabapentin	Gabapentin	Method Pharmaceuticals, LLC	ANDA	Current
58657-722	Gabapentin	Gabapentin	Method Pharmaceuticals, LLC	ANDA	Current
58657-722	Gabapentin	Gabapentin	Method Pharmaceuticals, LLC	ANDA	Current
69844-055	Gabapentin	Gabapentin	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-056	Gabapentin	Gabapentin	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-057	Gabapentin	Gabapentin	Graviti Pharmaceuticals Private Limited	ANDA	Current