Application 075128

Type: ANDA
Sponsor: WATSON LABS TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AFEDITAB CR	NIFEDIPINE	TABLET, EXTENDED RELEASE;ORAL	30MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075128-001	AFEDITAB CR	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL			2000-03-10

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 · 43 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	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075128-001	AFEDITAB CR	30MG	TABLET, EXTENDED RELEASE / ORAL	2000-03-10	`f41ea6bd6efb…`

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 generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	A-S Medication Solutions	3334ab6f-aeb0-4b78-8d17-f0aedd94f996	2026-02-11	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	REMEDYREPACK INC.	24e56333-5601-48fd-a263-f6be90983fb4	2026-02-10	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Oceanside Pharmaceuticals	fb6d8f32-198e-4ccf-bf25-069c03d624fd	2026-02-09	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
nifedipine	NIFEDIPINE	Oceanside Pharmaceuticals	c7874606-c71e-424c-b881-38697988e0d0	2026-02-09	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Oceanside Pharmaceuticals	ca5b0178-4e5f-4077-ada5-7058b0a03858	2026-02-05	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Upsher-Smith Laboratories, LLC	160271a8-7922-2107-e054-00144ff88e88	2026-01-19	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Upsher-Smith Laboratories, LLC	3bf4282f-b063-4d35-8ef0-6f48b98e9deb	2026-01-19	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
nifedipine	NIFEDIPINE	Elite Pharmaceutical Solution, Inc.	1df07edb-630d-4c70-a68c-bdbc607ce850	2026-01-13	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	7160331a-8735-4bc0-8cb9-a8014512a669	2026-01-12	Warnings, Adverse reactions	Name fallback 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 generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	8e5e126a-7da6-4ceb-b72b-5c9dcc7d7769	2026-01-06	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	A-S Medication Solutions	5a7951e7-f507-43e8-9bba-855b79daf170	2026-01-06	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	f8358be1-848c-d9eb-e053-6294a90a178c	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	f2f3564a-d43a-6c36-e053-2a95a90ae878	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	f32c0fc9-b4ad-6a1f-e053-2995a90acf61	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	da80fa84-9336-082c-e053-2a95a90a8987	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	d9dec600-4e11-8292-e053-2a95a90a6842	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	da565525-c77a-0571-e053-2995a90aaa11	2026-01-01	Warnings, Adverse reactions	Name fallback 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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43353-792	Afeditab	Nifedipine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
63629-4089	nifedipine	nifedipine	bryant ranch prepack	ANDA	Current
68151-4223	Afeditab	Nifedipine	Carilion Materials Management	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22420	ORIG	2005-07-22
30764	ORIG	2004-06-10
8530	ORIG	2000-03-10