Application 213252

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENOFIBRATE	FENOFIBRATE	TABLET;ORAL	54MG	No	No
002	FENOFIBRATE	FENOFIBRATE	TABLET;ORAL	160MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A213252-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL			2020-01-17
A213252-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL			2020-01-17

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 2 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-01-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-01-17	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL		2020-01-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL		2020-01-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A213252-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A213252-002	AB	1	`c0c555d07b60…`

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Limited	65ca643c-3b31-4e53-bc06-0e11418baf7d	2023-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213252 application number: ANDA213252 ndc (product): 46708-351 ndc (product): 46708-350
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	1e56492f-e2b1-4a07-b697-b59b3a0ac05e	2021-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213252 application number: ANDA213252 ndc (product): 62332-350 ndc (product): 62332-351

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-350	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-351	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Limited	ANDA	Current
62332-350	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-350	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-351	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-351	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current