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 5 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Alembic Pharmaceuticals Limited	1486f187-0ec6-4c70-8991-02c1493912b4	2022-11-28	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Alembic Pharmaceuticals Inc.	63f062f6-5669-434c-8ded-9801d8486dbf	2022-11-23	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Proficient Rx LP	d428aa4d-4cc0-4b1e-b9f6-40ae65a735d6	2022-03-01	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Proficient Rx LP	838d6e8f-37b0-48d3-b701-c4fa32a87b85	2020-02-01	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Proficient Rx LP	4b6418a8-600f-470e-adf1-56207bb25c38	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	09a04e5f-d3b0-4ee3-b12d-f74203262179	2019-06-06	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	95a53fc5-852d-4892-af20-2aaece9399ba	2018-09-13	Warnings, Adverse reactions	Name fallback generic name: NIFEDIPINE
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	36b07283-fc0e-4a14-b78f-1d2ab80e7f31	2018-05-07	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