Application 207799

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREGABALIN	PREGABALIN	CAPSULE;ORAL	75MG	No	No
002	PREGABALIN	PREGABALIN	CAPSULE;ORAL	100MG	No	No
003	PREGABALIN	PREGABALIN	CAPSULE;ORAL	150MG	No	No
004	PREGABALIN	PREGABALIN	CAPSULE;ORAL	200MG	No	No
005	PREGABALIN	PREGABALIN	CAPSULE;ORAL	225MG	No	No
006	PREGABALIN	PREGABALIN	CAPSULE;ORAL	300MG	No	No
007	PREGABALIN	PREGABALIN	CAPSULE;ORAL	25MG	No	No
008	PREGABALIN	PREGABALIN	CAPSULE;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A207799-001	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19
A207799-002	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19
A207799-003	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19
A207799-004	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19
A207799-005	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19
A207799-006	PREGABALIN	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19
A207799-007	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-09-30
A207799-008	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-09-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
A207799-001	AB
A207799-002	AB
A207799-003	AB
A207799-004	AB
A207799-005	AB
A207799-006	AB
A207799-007	AB
A207799-008	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 9 · 324 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
2026-09-14 22:38:34	2026-08	A207799-001	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-002	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-003	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-004	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-005	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-006	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-007	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-008	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-09-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207799-001	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-002	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-003	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-004	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-005	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-006	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-007	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-008	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207799-001	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-002	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-003	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-004	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-005	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-006	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-007	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-008	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-001	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-002	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-003	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-004	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-005	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-006	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-007	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-008	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207799-001	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-002	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-003	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-004	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-005	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-006	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-007	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-008	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-09-30	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 324 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207799-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207799-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207799-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207799-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-008	AB	1	`6a471c1ec25d…`

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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Bryant Ranch Prepack	8923d776-b374-4c06-a208-abeffb1ba578	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	Proficient Rx LP	68829d7b-ab40-429e-92dc-91f8a0d49afd	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799 ndc (product): 71205-608
Pregabalin	PREGABALIN	Proficient Rx LP	a1545bbb-b337-4760-ab4c-fb76ab019337	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799 ndc (product): 71205-621
Pregabalin	PREGABALIN	Proficient Rx LP	1503dd3b-688b-4702-8fc1-954b5ffe4235	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799 ndc (product): 71205-639

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 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67877-462	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-463	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-464	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-464	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-464	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-465	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-465	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-465	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-466	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-466	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-466	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-467	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-467	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-467	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-468	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-468	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-468	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-469	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-469	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
67877-469	Pregabalin	Pregabalin	Ascend Laboratories, LLC	ANDA	Current
70518-3597	Pregabalin	Pregabalin	REMEDYREPACK INC.	ANDA	Current
71205-608	Pregabalin	Pregabalin	Proficient Rx LP	ANDA	Current
71205-608	Pregabalin	Pregabalin	Proficient Rx LP	ANDA	Current
71205-621	Pregabalin	Pregabalin	Proficient Rx LP	ANDA	Current
71205-621	Pregabalin	Pregabalin	Proficient Rx LP	ANDA	Current
71205-639	Pregabalin	Pregabalin	Proficient Rx LP	ANDA	Current
71205-639	Pregabalin	Pregabalin	Proficient Rx LP	ANDA	Current
71335-1740	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1740	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1745	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1745	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1758	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
71335-1758	Pregabalin	Pregabalin	Bryant Ranch Prepack	ANDA	Current
80425-0160	Lyrica	Pregabalin 300mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0160	Pregabalin	Pregabalin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0160	Pregabalin	Pregabalin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0160	Pregabalin	Pregabalin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0185	PREGABALIN	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0185	PREGABALIN	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current