Application 210012

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NIFEDIPINE	NIFEDIPINE	TABLET, EXTENDED RELEASE;ORAL	30MG	No	No
002	NIFEDIPINE	NIFEDIPINE	TABLET, EXTENDED RELEASE;ORAL	60MG	No	No
003	NIFEDIPINE	NIFEDIPINE	TABLET, EXTENDED RELEASE;ORAL	90MG	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	TE codes	Approval date
A210012-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19
A210012-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19
A210012-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210012-001	AB2
A210012-002	AB2
A210012-003	AB2

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A210012-001	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210012-002	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210012-003	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210012-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210012-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210012-003	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210012-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210012-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210012-003	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210012-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210012-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210012-003	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210012-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210012-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210012-003	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210012-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210012-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210012-003	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210012-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210012-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210012-003	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210012-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210012-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210012-003	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210012-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210012-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210012-003	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210012-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210012-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210012-003	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210012-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210012-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210012-003	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210012-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210012-002	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210012-003	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210012-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210012-002	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210012-003	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210012-001	AB2	1	`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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Zydus Lifesciences Limited	ac3f68b2-29b5-45c1-b6a2-54704dc3143e	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210012 application number: ANDA210012 ndc (product): 70771-1191 ndc (product): 70771-1192 ndc (product): 70771-1190
Nifedipine	NIFEDIPINE	Zydus Pharmaceuticals (USA) Inc.	657221d5-9eb8-42f9-8cdc-39cefc386f51	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210012 application number: ANDA210012 ndc (product): 68382-686 ndc (product): 68382-685 ndc (product): 68382-687

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-685	Nifedipine	Nifedipine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-685	Nifedipine	Nifedipine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-685	Nifedipine	Nifedipine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-686	Nifedipine	Nifedipine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-686	Nifedipine	Nifedipine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-686	Nifedipine	Nifedipine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-687	Nifedipine	Nifedipine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-687	Nifedipine	Nifedipine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-687	Nifedipine	Nifedipine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1190	Nifedipine	Nifedipine	Cadila Healthcare Limited	ANDA	Current
70771-1190	Nifedipine	Nifedipine	Cadila Healthcare Limited	ANDA	Current
70771-1190	Nifedipine	Nifedipine	Cadila Healthcare Limited	ANDA	Current
70771-1191	Nifedipine	Nifedipine	Cadila Healthcare Limited	ANDA	Current
70771-1191	Nifedipine	Nifedipine	Cadila Healthcare Limited	ANDA	Current
70771-1191	Nifedipine	Nifedipine	Cadila Healthcare Limited	ANDA	Current
70771-1192	Nifedipine	Nifedipine	Cadila Healthcare Limited	ANDA	Current
70771-1192	Nifedipine	Nifedipine	Cadila Healthcare Limited	ANDA	Current
70771-1192	Nifedipine	Nifedipine	Cadila Healthcare Limited	ANDA	Current