Application 201071

Type: ANDA
Sponsor: MYLAN

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	Approval date
A201071-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03
A201071-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03
A201071-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A201071-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201071-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201071-003	AB1	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201071-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201071-002	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201071-003	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201071-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201071-002	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201071-003	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201071-001	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201071-002	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201071-003	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201071-001	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201071-002	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201071-003	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201071-001	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201071-002	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201071-003	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201071-001	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201071-002	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201071-003	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201071-001	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201071-002	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201071-003	AB1	1	`ea99ee380514…`

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 5 · 88 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	A-S Medication Solutions	446505e8-cd68-4037-bebe-954a893dc67b	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	A-S Medication Solutions	3334ab6f-aeb0-4b78-8d17-f0aedd94f996	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	REMEDYREPACK INC.	24e56333-5601-48fd-a263-f6be90983fb4	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Oceanside Pharmaceuticals	fb6d8f32-198e-4ccf-bf25-069c03d624fd	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
nifedipine	NIFEDIPINE	Oceanside Pharmaceuticals	c7874606-c71e-424c-b881-38697988e0d0	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Oceanside Pharmaceuticals	ca5b0178-4e5f-4077-ada5-7058b0a03858	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Upsher-Smith Laboratories, LLC	160271a8-7922-2107-e054-00144ff88e88	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Upsher-Smith Laboratories, LLC	3bf4282f-b063-4d35-8ef0-6f48b98e9deb	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
nifedipine	NIFEDIPINE	Elite Pharmaceutical Solution, Inc.	1df07edb-630d-4c70-a68c-bdbc607ce850	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	7160331a-8735-4bc0-8cb9-a8014512a669	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine ER	NIFEDIPINE	AvPAK	d1a78ff2-7672-3e69-00ef-63d203c80484	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	89723620-474e-4b16-9f57-4e927efc401c	2026-01-06	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	8e5e126a-7da6-4ceb-b72b-5c9dcc7d7769	2026-01-06	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	A-S Medication Solutions	5a7951e7-f507-43e8-9bba-855b79daf170	2026-01-06	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	f8358be1-848c-d9eb-e053-6294a90a178c	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	f2f3564a-d43a-6c36-e053-2a95a90ae878	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	f32c0fc9-b4ad-6a1f-e053-2995a90acf61	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	da80fa84-9336-082c-e053-2a95a90a8987	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	d9dec600-4e11-8292-e053-2a95a90a6842	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	da565525-c77a-0571-e053-2995a90aaa11	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0353	Nifedipine	nifedipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0360	Nifedipine	nifedipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0390	Nifedipine	nifedipine	Mylan Pharmaceuticals Inc.	ANDA	Current
43353-750	Nifedipine	nifedipine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-750	Nifedipine	nifedipine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-836	Nifedipine	nifedipine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-836	Nifedipine	nifedipine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-929	Nifedipine	nifedipine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-2917	Nifedipine	nifedipine	A-S Medication Solutions	ANDA	Current
70518-0747	Nifedipine	nifedipine	REMEDYREPACK INC.	ANDA	Current
70518-0747	Nifedipine	nifedipine	REMEDYREPACK INC.	ANDA	Current