Application 090649

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 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	Approval date
A090649-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21
A090649-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21
A090649-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`8072bd15b7f6…`

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	A090649-001	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090649-002	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090649-003	AB2	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A090649-001	AB2	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090649-002	AB2	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090649-003	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090649-001	AB2	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090649-002	AB2	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090649-003	AB2	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 1 of 5 · 89 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Major Pharmaceuticals	acb493a3-b8f2-41a9-8ab2-550d97c4592a	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	St. Mary's Medical Park Pharmacy	1add684f-d082-72cc-e063-6394a90a1214	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	St. Mary's Medical Park Pharmacy	1ab8945b-bea5-9827-e063-6294a90af334	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Golden State Medical Supply, Inc.	d9a501be-8523-3924-e053-2995a90a8569	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
nifedipine	NIFEDIPINE	Bryant Ranch Prepack	d7475c68-6310-4b9a-81c1-9209a9ade75f	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	e1cd5011-b80e-4b1b-8729-56260b8b3c26	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Coupler LLC	518d39af-0be1-acbc-e063-6294a90a4ada	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Major Pharmaceuticals	41aa6fbd-96c1-40f7-92d4-cfdd2d5325e9	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	REMEDYREPACK INC.	bddfd658-ac61-4ba2-a3fa-07acc35d368a	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	59724871-b495-4911-a86d-20069ec42edd	2026-04-22	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Ingenus Pharmaceuticals, LLC	4d02eba2-e964-4fa7-aaae-25949b5f0316	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Cardinal Health 107, LLC	472621b6-c2b7-4582-9ceb-7cead55ff247	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Ingenus Pharmaceuticals, LLC	4d3e11d2-d320-45d3-96c8-48322202b504	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	cb9d013a-2303-4e1d-a539-8ff04d5ec91d	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	0b4e9bbc-4c16-4611-9ea2-903852804227	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	888b3fac-2f2f-42b8-92d1-d37b6ed225a5	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Major Pharmaceuticals	b885b6b5-71c6-4799-8b23-5ee8c17938a0	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Cardinal Health 107, LLC	c98ecf77-ae9a-438b-9bad-ffbed25d95bc	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0480	Nifedipine	nifedipine	Mylan Pharmaceuticals Inc	ANDA	Current
0378-0480	Nifedipine	nifedipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0481	Nifedipine	nifedipine	Mylan Pharmaceuticals Inc	ANDA	Current
0378-0481	Nifedipine	nifedipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0494	Nifedipine	nifedipine	Mylan Pharmaceuticals Inc	ANDA	Current
0378-0494	Nifedipine	nifedipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-5541	Nifedipine	nifedipine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-6563	Nifedipine	nifedipine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7571	Nifedipine	Nifedipine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
51079-400	Nifedipine	nifedipine	Mylan Institutional Inc.	ANDA	Current
51079-896	Nifedipine	nifedipine	Mylan Institutional Inc.	ANDA	Current
51079-897	Nifedipine	nifedipine	Mylan Institutional Inc.	ANDA	Current
55154-5363	Nifedipine	nifedipine	Cardinal Health	ANDA	Current
55154-5363	Nifedipine	nifedipine	Cardinal Health	ANDA	Current
55154-5368	Nifedipine	nifedipine	Cardinal Health	ANDA	Current
55154-5368	Nifedipine	nifedipine	Cardinal Health	ANDA	Current
68788-9885	Nifedipine	nifedipine	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9886	Nifedipine	nifedipine	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0960	Nifedipine	nifedipine	REMEDYREPACK INC.	ANDA	Current
70518-0960	Nifedipine	nifedipine	REMEDYREPACK INC.	ANDA	Current