Application 216019

Type: ANDA
Sponsor: PHARMADAX INC

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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216019-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL			2022-11-18
A216019-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL			2022-11-18

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 2 · 52 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	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216019-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216019-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2022-11-18	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-05-13 08:27 UTC	2023-05	A216019-001	AB2	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A216019-002	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216019-001	AB2	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A216019-002	AB2	1	`3bdfa0b2c4d7…`

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 4 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Aurobindo Pharma Limited	eb70b7ff-f9f0-41d0-901a-f4c04ae9ed46	2024-12-24	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Zydus Lifesciences Limited	ac3f68b2-29b5-45c1-b6a2-54704dc3143e	2024-12-11	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Zydus Pharmaceuticals (USA) Inc.	657221d5-9eb8-42f9-8cdc-39cefc386f51	2024-12-11	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	NuCare Pharmaceuticals,Inc.	27d6c9c5-5a45-9cfc-e063-6394a90a7202	2024-11-26	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	NCS HealthCare of KY, LLC dba Vangard Labs	0cabe053-3b7e-4dcb-8441-ef7821bb6f68	2024-10-18	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	NuCare Pharmaceuticals,Inc.	9b0263a7-c492-40ea-e053-2a95a90a561e	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	NuCare Pharmaceuticals,Inc.	5927fcff-9d1a-8322-e053-2991aa0ad289	2024-07-18	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	1b98b011-793c-ed92-e063-6294a90ac2bc	2024-06-23	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	81e6c8e7-e826-4abb-ad58-1dee62091a66	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
NIFEDIPINE	NIFEDIPINE	Zydus Lifesciences Limited	925e2ea9-f51a-4b89-ab5d-ce590b6c4d85	2024-01-17	Warnings, Adverse reactions	Name fallback brand name: NIFEDIPINE generic name: NIFEDIPINE
NIFEDIPINE	NIFEDIPINE	Zydus Pharmaceuticals (USA) Inc.	1c857df2-9cce-40de-95c3-b1274ed1e1bc	2024-01-16	Warnings, Adverse reactions	Name fallback brand name: NIFEDIPINE generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	A-S Medication Solutions	4a4d5b67-6ce7-4098-9324-f68084e800e4	2023-10-30	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	6a68f67f-5b68-4f83-aad8-fc3177f5a0a4	2023-10-25	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b8b8cfee-ea71-44c2-81af-675efecfdf15	2023-08-03	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	71a4e00b-8386-4da1-8515-a0e7e8db104d	2023-06-02	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Lannett Company, Inc.	331db003-cc8e-4509-9415-20e48c5cc5b2	2023-05-30	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	A-S Medication Solutions	ec13ec71-626f-4664-b264-f67ba72071ae	2023-05-16	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	4c4f8a8e-3995-4d2e-85d4-b6a45f5fac3e	2023-05-08	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	A-S Medication Solutions	af5a6330-1819-4724-9f08-da45ac9fb478	2023-03-12	Warnings, Adverse reactions	Name fallback brand name: Nifedipine generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	75bb3a1f-3cb7-4450-8e59-27521a1ebc25	2023-02-01	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.