Application 210606

Type: ANDA
Sponsor: GRAVITI PHARMS

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 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
A210606-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2018-08-17
A210606-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB		2018-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210606-001	AB
A210606-002	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 3 · 82 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	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL		2018-08-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL		2018-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A210606-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210606-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210606-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210606-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210606-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210606-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210606-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210606-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210606-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210606-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210606-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210606-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210606-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210606-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210606-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210606-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210606-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210606-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210606-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210606-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210606-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210606-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210606-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210606-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210606-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210606-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210606-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210606-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210606-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210606-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210606-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210606-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210606-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210606-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210606-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210606-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210606-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210606-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210606-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210606-002	AB	1	`87673890dc5c…`

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	Leading Pharma, LLC	f73a40ef-1513-4a07-a5a9-51efb30bf560	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210606 application number: ANDA210606 ndc (product): 69315-289 ndc (product): 69315-290
FENOFIBRATE	FENOFIBRATE	Laurus Labs Limited	8e58c13a-8088-4fed-86cc-52530de5aa45	2022-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210606 application number: ANDA210606 ndc (product): 42385-936 ndc (product): 42385-935

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42385-935	FENOFIBRATE	FENOFIBRATE	Laurus Labs Limited	ANDA	Current
42385-935	FENOFIBRATE	FENOFIBRATE	Laurus Labs Limited	ANDA	Current
42385-935	FENOFIBRATE	FENOFIBRATE	Laurus Labs Limited	ANDA	Current
42385-935	FENOFIBRATE	FENOFIBRATE	Laurus Labs Limited	ANDA	Current
42385-936	FENOFIBRATE	FENOFIBRATE	Laurus Labs Limited	ANDA	Current
42385-936	FENOFIBRATE	FENOFIBRATE	Laurus Labs Limited	ANDA	Current
42385-936	FENOFIBRATE	FENOFIBRATE	Laurus Labs Limited	ANDA	Current
42385-936	FENOFIBRATE	FENOFIBRATE	Laurus Labs Limited	ANDA	Current
69315-289	Fenofibrate	Fenofibrate	Leading Pharma, LLC	ANDA	Current
69315-290	Fenofibrate	Fenofibrate	Leading Pharma, LLC	ANDA	Current
69844-008	Fenofibrate	fenofibrate	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-008	Fenofibrate	fenofibrate	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-008	Fenofibrate	fenofibrate	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-008	Fenofibrate	fenofibrate	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-008	Fenofibrate	fenofibrate	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-009	Fenofibrate	fenofibrate	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-009	Fenofibrate	fenofibrate	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-009	Fenofibrate	fenofibrate	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-009	Fenofibrate	fenofibrate	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-009	Fenofibrate	fenofibrate	Graviti Pharmaceuticals Private Limited	ANDA	Current