Application 213864

Type: ANDA
Sponsor: MANKIND PHARMA

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 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
A213864-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2020-06-12
A213864-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB		2020-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213864-001	AB
A213864-002	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 · 76 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
2026-08-18 06:07:40	2026-07	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213864-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213864-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213864-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213864-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213864-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213864-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213864-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213864-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213864-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213864-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213864-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213864-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213864-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213864-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213864-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213864-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213864-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213864-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213864-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213864-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213864-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213864-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213864-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213864-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213864-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213864-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213864-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213864-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213864-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213864-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213864-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213864-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213864-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213864-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213864-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213864-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213864-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213864-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213864-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213864-002	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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FENOFIBRATE	FENOFIBRATE	REMEDYREPACK INC.	3b6c5ebd-a8bc-4502-8b66-f4e58914815b	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864 ndc (product): 70518-2907
FENOFIBRATE	FENOFIBRATE	St. Mary's Medical Park Pharmacy	b92fb19a-d0df-426e-e053-2995a90ab379	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864 ndc (product): 60760-318
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	df9f67d6-3cd9-4f44-8020-2d6ef53c30b5	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864
FENOFIBRATE	FENOFIBRATE	Preferred Pharmaceuticals Inc.	e573b3f1-5a4c-4a19-9f0f-ee797b379a08	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864 ndc (product): 68788-7816
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	f443dd79-46da-4b02-8188-7417d39cf975	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864
FENOFIBRATE	FENOFIBRATE	REMEDYREPACK INC.	b79efcf4-6016-4a1f-b83f-be00baa25c21	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864 ndc (product): 70518-2947
FENOFIBRATE	FENOFIBRATE	Northwind Health Company, LLC	f7590970-c54d-24e9-e053-6294a90ac400	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864
FENOFIBRATE	FENOFIBRATE	NorthStar RxLLC	3b448774-aebf-45fe-92f1-b8eca53cf09b	2025-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864
FENOFIBRATE	FENOFIBRATE	Major Pharmaceuticals	3f4e5db8-5bfb-4b24-8465-9757cbaad2be	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864
FENOFIBRATE	FENOFIBRATE	Lifestar Pharma LLC	1da57e8c-3977-43e1-aa7e-229760203f7d	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864 ndc (product): 70756-215 ndc (product): 70756-214
FENOFIBRATE	FENOFIBRATE	Bryant Ranch Prepack	d34f9fa3-39ae-4b8e-8f29-0d5c655c50b5	2023-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864 ndc (product): 71335-1756
FENOFIBRATE	FENOFIBRATE	Proficient Rx LP	26f8f793-fb7a-4327-9441-d8737fe1ff11	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864 ndc (product): 71205-666

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60760-318	FENOFIBRATE	FENOFIBRATE	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-318	FENOFIBRATE	FENOFIBRATE	St. Mary's Medical Park Pharmacy	ANDA	Current
68071-2540	FENOFIBRATE	FENOFIBRATE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2540	FENOFIBRATE	FENOFIBRATE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7816	FENOFIBRATE	FENOFIBRATE	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7816	FENOFIBRATE	FENOFIBRATE	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7816	FENOFIBRATE	FENOFIBRATE	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2907	FENOFIBRATE	FENOFIBRATE	REMEDYREPACK INC.	ANDA	Current
70518-2907	FENOFIBRATE	FENOFIBRATE	REMEDYREPACK INC.	ANDA	Current
70518-2947	FENOFIBRATE	FENOFIBRATE	REMEDYREPACK INC.	ANDA	Current
70518-2947	FENOFIBRATE	FENOFIBRATE	REMEDYREPACK INC.	ANDA	Current
70756-214	FENOFIBRATE	FENOFIBRATE	Lifestar Pharma LLC	ANDA	Current
70756-214	FENOFIBRATE	FENOFIBRATE	Lifestar Pharma LLC	ANDA	Current
70756-214	FENOFIBRATE	FENOFIBRATE	Lifestar Pharma LLC	ANDA	Current
70756-215	FENOFIBRATE	FENOFIBRATE	Lifestar Pharma LLC	ANDA	Current
70756-215	FENOFIBRATE	FENOFIBRATE	Lifestar Pharma LLC	ANDA	Current
70756-215	FENOFIBRATE	FENOFIBRATE	Lifestar Pharma LLC	ANDA	Current
71205-666	FENOFIBRATE	FENOFIBRATE	Proficient Rx LP	ANDA	Current
71335-1756	FENOFIBRATE	FENOFIBRATE	Bryant Ranch Prepack	ANDA	Current