Application 213226

Type: ANDA
Sponsor: MSN LABORATORIES PRIVATE LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREGABALIN	PREGABALIN	TABLET, EXTENDED RELEASE;ORAL	82.5MG	No	No
002	PREGABALIN	PREGABALIN	TABLET, EXTENDED RELEASE;ORAL	165MG	No	No
003	PREGABALIN	PREGABALIN	TABLET, EXTENDED RELEASE;ORAL	330MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A213226-001	PREGABALIN	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13
A213226-002	PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13
A213226-003	PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213226-001	AB
A213226-002	AB
A213226-003	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 3 · 102 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
2026-08-18 06:07:40	2026-07	A213226-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213226-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213226-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213226-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213226-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213226-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213226-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213226-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213226-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213226-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213226-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213226-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213226-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213226-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213226-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213226-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213226-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213226-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213226-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213226-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213226-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213226-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213226-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213226-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213226-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213226-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213226-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213226-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213226-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213226-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213226-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213226-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213226-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213226-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213226-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213226-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213226-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213226-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213226-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213226-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-04-13	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213226-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213226-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213226-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213226-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213226-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213226-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213226-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213226-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213226-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213226-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213226-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213226-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213226-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213226-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213226-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213226-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213226-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213226-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213226-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213226-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213226-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213226-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213226-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213226-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213226-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213226-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213226-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213226-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213226-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213226-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213226-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213226-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213226-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213226-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213226-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213226-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213226-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213226-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213226-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213226-001	AB	1	`1e350fbaab3a…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PREGABALIN	PREGABALIN	Novadoz Pharmaceuticals LLC	f6aa5977-97c8-4a56-8e35-d9ab5cc24369	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213226 application number: ANDA213226 ndc (product): 72205-079 ndc (product): 72205-078 ndc (product): 72205-077

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55700-955	PREGABALIN	PREGABALIN	Quality Care Products, LLC	ANDA	Current
55700-956	PREGABALIN	PREGABALIN	Quality Care Products, LLC	ANDA	Current
69539-127	PREGABALIN	PREGABALIN	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-127	PREGABALIN	PREGABALIN	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-128	PREGABALIN	PREGABALIN	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-128	PREGABALIN	PREGABALIN	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-129	PREGABALIN	PREGABALIN	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-129	PREGABALIN	PREGABALIN	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
72205-077	PREGABALIN	PREGABALIN	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-078	PREGABALIN	PREGABALIN	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-079	PREGABALIN	PREGABALIN	Novadoz Pharmaceuticals LLC	ANDA	Current