Application 200913

Type: ANDA
Sponsor: MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENOFIBRIC ACID	CHOLINE FENOFIBRATE	CAPSULE, DELAYED RELEASE;ORAL	EQ 45MG FENOFIBRIC ACID	No	No
002	FENOFIBRIC ACID	CHOLINE FENOFIBRATE	CAPSULE, DELAYED RELEASE;ORAL	EQ 135MG FENOFIBRIC ACID	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A200913-001	FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL			2013-03-25
A200913-002	FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL			2013-03-25

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200913-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200913-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	2013-03-25	`bb7c543d1eb4…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FENOFIBRIC ACID	FENOFIBRIC ACID	Leading Pharma, LLC	daa488be-f580-430c-a72c-80ac31bb3e40	2025-08-22	Warnings, Adverse reactions	Name fallback brand name: FENOFIBRIC ACID
FENOFIBRIC ACID	FENOFIBRIC ACID	Aurobindo Pharma Limited	9ad201de-fa62-4c49-bc61-ee09b9ba434c	2025-08-02	Warnings, Adverse reactions	Name fallback brand name: FENOFIBRIC ACID
Fenofibric Acid	FENOFIBRIC ACID	Alembic Pharmaceuticals Inc.	8ffcb173-095a-4550-84f2-18959ad2aab8	2025-07-14	Warnings, Adverse reactions	Name fallback brand name: Fenofibric Acid
Fenofibric acid	FENOFIBRIC ACID	Macleods Pharmaceuticals Limited	af225492-73b0-49bb-b32f-5399c3c3ec6d	2025-07-03	Warnings, Adverse reactions	Name fallback brand name: Fenofibric acid
Fenofibric Acid	FENOFIBRIC ACID	Amneal Pharmaceuticals of New York LLC	e73404c5-e0ee-48e9-8b09-7a00d7e18e6c	2025-06-23	Warnings, Adverse reactions	Name fallback brand name: Fenofibric Acid
Fenofibric acid	FENOFIBRIC ACID	Lupin Pharmaceuticals, Inc.	b9a3f97c-9e31-4a5f-822f-c9d45e394493	2023-12-08	Warnings, Adverse reactions	Name fallback brand name: Fenofibric acid
Fenofibric Acid	FENOFIBRIC ACID	Alembic Pharmaceuticals Limited	c880d43a-fa8c-4f7a-a488-419bae7cc311	2023-01-30	Warnings, Adverse reactions	Name fallback brand name: Fenofibric Acid

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
0378-2589	Fenofibric Acid	fenofibric acid	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2589	Fenofibric Acid	fenofibric acid	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2589	Fenofibric Acid	fenofibric acid	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2590	Fenofibric Acid	fenofibric acid	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2590	Fenofibric Acid	fenofibric acid	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2590	Fenofibric Acid	fenofibric acid	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32072	ORIG	2013-03-28