Application 211626

Type: ANDA
Sponsor: GRAVITI PHARMS

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 1.

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
A211626-001	FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB		2019-07-18
A211626-002	FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB		2019-07-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A211626-001	AB
A211626-002	AB

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 · 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
2026-02-19 14:30 UTC	2026-02	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211626-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211626-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211626-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211626-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211626-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211626-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211626-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211626-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211626-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211626-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211626-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211626-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211626-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211626-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211626-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211626-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211626-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211626-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211626-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211626-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211626-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211626-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211626-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211626-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211626-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211626-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211626-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211626-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211626-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211626-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211626-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211626-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211626-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211626-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211626-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211626-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211626-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211626-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211626-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211626-002	AB	1	`782e0a99824c…`

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
FENOFIBRIC ACID	FENOFIBRIC ACID	Leading Pharma, LLC	daa488be-f580-430c-a72c-80ac31bb3e40	2025-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211626 application number: ANDA211626 ndc (product): 69315-282 ndc (product): 69315-281
FENOFIBRIC ACID DELAYED-RELEASE	FENOFIBRIC ACID	Laurus Labs Limited	302ffbf8-448e-4729-949f-40d457e30ab4	2022-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211626 application number: ANDA211626 ndc (product): 42385-944 ndc (product): 42385-945

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42385-944	FENOFIBRIC ACID DELAYED-RELEASE	FENOFIBRIC ACID	Laurus Labs Limited	ANDA	Current
42385-944	FENOFIBRIC ACID DELAYED-RELEASE	FENOFIBRIC ACID	Laurus Labs Limited	ANDA	Current
42385-944	FENOFIBRIC ACID DELAYED-RELEASE	FENOFIBRIC ACID	Laurus Labs Limited	ANDA	Current
42385-945	FENOFIBRIC ACID DELAYED-RELEASE	Fenofibric Acid	Laurus Labs Limited	ANDA	Current
42385-945	FENOFIBRIC ACID DELAYED-RELEASE	Fenofibric Acid	Laurus Labs Limited	ANDA	Current
42385-945	FENOFIBRIC ACID DELAYED-RELEASE	Fenofibric Acid	Laurus Labs Limited	ANDA	Current
69315-281	FENOFIBRIC ACID	FENOFIBRIC ACID	Leading Pharma, LLC	ANDA	Current
69315-282	FENOFIBRIC ACID	FENOFIBRIC ACID	Leading Pharma, LLC	ANDA	Current
69844-022	FENOFIBRIC ACID DELAYED-RELEASE	FENOFIBRIC ACID	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-022	FENOFIBRIC ACID DELAYED-RELEASE	FENOFIBRIC ACID	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-022	FENOFIBRIC ACID DELAYED-RELEASE	FENOFIBRIC ACID	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-022	FENOFIBRIC ACID DELAYED-RELEASE	FENOFIBRIC ACID	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-023	FENOFIBRIC ACID DELAYED-RELEASE	Fenofibric Acid	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-023	FENOFIBRIC ACID DELAYED-RELEASE	Fenofibric Acid	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-023	FENOFIBRIC ACID DELAYED-RELEASE	Fenofibric Acid	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-023	FENOFIBRIC ACID DELAYED-RELEASE	Fenofibric Acid	Graviti Pharmaceuticals Private Limited	ANDA	Current