Application 021695

Type: NDA
Sponsor: LUPIN ATLANTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ANTARA (MICRONIZED)	FENOFIBRATE	CAPSULE;ORAL	43MG	Yes	No
002	ANTARA (MICRONIZED)	FENOFIBRATE	CAPSULE;ORAL	87MG	No	No
003	ANTARA (MICRONIZED)	FENOFIBRATE	CAPSULE;ORAL	130MG	Yes	Yes
004	ANTARA (MICRONIZED)	FENOFIBRATE	CAPSULE;ORAL	30MG	Yes	No
005	ANTARA (MICRONIZED)	FENOFIBRATE	CAPSULE;ORAL	90MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021695-001	ANTARA (MICRONIZED)	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	RLD	2004-11-30
N021695-002	ANTARA (MICRONIZED)	FENOFIBRATE	87MG	CAPSULE / ORAL			2004-11-30
N021695-003	ANTARA (MICRONIZED)	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	RLD, RS	2004-11-30
N021695-004	ANTARA (MICRONIZED)	FENOFIBRATE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18
N021695-005	ANTARA (MICRONIZED)	FENOFIBRATE	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021695-001	AB
N021695-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021695-005	9314447	2033-05-31	U-1447	Drug product	2016-05-02
N021695-005	9314447	2033-05-31	U-1448	Drug product	2016-05-02

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 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021695-001	ANTARA (MICRONIZED)	43MG	CAPSULE / ORAL	AB	RLD	2004-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021695-002	ANTARA (MICRONIZED)	87MG	CAPSULE / ORAL			2004-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021695-003	ANTARA (MICRONIZED)	130MG	CAPSULE / ORAL	AB	RLD, RS	2004-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021695-004	ANTARA (MICRONIZED)	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021695-005	ANTARA (MICRONIZED)	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021695-001	ANTARA (MICRONIZED)	43MG	CAPSULE / ORAL	AB	RLD	2004-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021695-002	ANTARA (MICRONIZED)	87MG	CAPSULE / ORAL			2004-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021695-003	ANTARA (MICRONIZED)	130MG	CAPSULE / ORAL	AB	RLD, RS	2004-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021695-004	ANTARA (MICRONIZED)	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021695-005	ANTARA (MICRONIZED)	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021695-001	ANTARA (MICRONIZED)	43MG	CAPSULE / ORAL	AB	RLD	2004-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021695-002	ANTARA (MICRONIZED)	87MG	CAPSULE / ORAL			2004-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021695-003	ANTARA (MICRONIZED)	130MG	CAPSULE / ORAL	AB	RLD, RS	2004-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021695-004	ANTARA (MICRONIZED)	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021695-005	ANTARA (MICRONIZED)	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-001	ANTARA (MICRONIZED)	43MG	CAPSULE / ORAL	AB	RLD	2004-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-002	ANTARA (MICRONIZED)	87MG	CAPSULE / ORAL			2004-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-003	ANTARA (MICRONIZED)	130MG	CAPSULE / ORAL	AB	RLD, RS	2004-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-004	ANTARA (MICRONIZED)	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-005	ANTARA (MICRONIZED)	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021695-001	ANTARA (MICRONIZED)	43MG	CAPSULE / ORAL	AB	RLD	2004-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-002	ANTARA (MICRONIZED)	87MG	CAPSULE / ORAL			2004-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-003	ANTARA (MICRONIZED)	130MG	CAPSULE / ORAL	AB	RLD, RS	2004-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-004	ANTARA (MICRONIZED)	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-005	ANTARA (MICRONIZED)	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-001	ANTARA (MICRONIZED)	43MG	CAPSULE / ORAL	AB	RLD	2004-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-002	ANTARA (MICRONIZED)	87MG	CAPSULE / ORAL			2004-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-003	ANTARA (MICRONIZED)	130MG	CAPSULE / ORAL	AB	RLD, RS	2004-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-004	ANTARA (MICRONIZED)	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-005	ANTARA (MICRONIZED)	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-001	ANTARA (MICRONIZED)	43MG	CAPSULE / ORAL	AB	RLD	2004-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-002	ANTARA (MICRONIZED)	87MG	CAPSULE / ORAL			2004-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-003	ANTARA (MICRONIZED)	130MG	CAPSULE / ORAL	AB	RLD, RS	2004-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-004	ANTARA (MICRONIZED)	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-005	ANTARA (MICRONIZED)	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-001	ANTARA (MICRONIZED)	43MG	CAPSULE / ORAL	AB	RLD	2004-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-002	ANTARA (MICRONIZED)	87MG	CAPSULE / ORAL			2004-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-003	ANTARA (MICRONIZED)	130MG	CAPSULE / ORAL	AB	RLD, RS	2004-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-004	ANTARA (MICRONIZED)	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-005	ANTARA (MICRONIZED)	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	N021695-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021695-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021695-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021695-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021695-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021695-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021695-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021695-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021695-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021695-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021695-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021695-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021695-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021695-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021695-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021695-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021695-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021695-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021695-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021695-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021695-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021695-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021695-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021695-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021695-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021695-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021695-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021695-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021695-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021695-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021695-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021695-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021695-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021695-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021695-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021695-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021695-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021695-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021695-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021695-003	AB	1	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 278 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021695-005	9314447	2033-05-31	U-1447	Drug product	2016-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021695-005	9314447	2033-05-31	U-1448	Drug product	2016-05-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021695-005	9314447	2033-05-31	U-1447	Drug product	2016-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021695-005	9314447	2033-05-31	U-1448	Drug product	2016-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021695-005	9314447	2033-05-31	U-1447	Drug product	2016-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021695-005	9314447	2033-05-31	U-1448	Drug product	2016-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-004	8026281	2025-04-22	U-1448			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-004	8026281	2025-04-22	U-1447			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-005	8026281	2025-04-22	U-1447			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-005	8026281	2025-04-22	U-1448			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-005	9314447	2033-05-31	U-1447	Drug product	2016-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-005	9314447	2033-05-31	U-1448	Drug product	2016-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021695-004	8026281	2025-04-22	U-1448			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-004	8026281	2025-04-22	U-1447			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-005	8026281	2025-04-22	U-1447			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-005	8026281	2025-04-22	U-1448			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-005	9314447	2033-05-31	U-1447	Drug product	2016-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-005	9314447	2033-05-31	U-1448	Drug product	2016-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-004	8026281	2025-04-22	U-1448			`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-004	8026281	2025-04-22	U-1447			`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-005	8026281	2025-04-22	U-1447			`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-005	8026281	2025-04-22	U-1448			`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-005	9314447	2033-05-31	U-1447	Drug product	2016-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-005	9314447	2033-05-31	U-1448	Drug product	2016-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-004	8026281	2025-04-22	U-1448			`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-004	8026281	2025-04-22	U-1447			`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-005	8026281	2025-04-22	U-1447			`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-005	8026281	2025-04-22	U-1448			`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-005	9314447	2033-05-31	U-1447	Drug product	2016-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-005	9314447	2033-05-31	U-1448	Drug product	2016-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-004	8026281	2025-04-22	U-1448			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-004	8026281	2025-04-22	U-1447			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-005	8026281	2025-04-22	U-1447			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-005	8026281	2025-04-22	U-1448			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-005	9314447	2033-05-31	U-1447	Drug product	2016-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-005	9314447	2033-05-31	U-1448	Drug product	2016-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021695-004	8026281	2025-04-22	U-1448			`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021695-004	8026281	2025-04-22	U-1447			`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021695-005	8026281	2025-04-22	U-1447			`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021695-005	8026281	2025-04-22	U-1448			`2680178bc6a6…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ANTARA	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	24790a18-0291-4b88-a724-acac43b616ce	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021695 application number: NDA021695 ndc (product): 27437-110 ndc (product): 27437-109
Fenofibrate	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	37b25526-0bd0-4459-a4be-f3a6893506f9	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021695 application number: NDA021695 ndc (product): 68180-131 ndc (product): 68180-130
Antara	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	12ebf783-64df-4ffa-9e84-f8fdf4d245d4	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021695 application number: NDA021695 ndc (product): 27437-108 ndc (product): 27437-107

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 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27437-107	Antara	fenofibrate	Lupin Pharmaceuticals, Inc.	NDA	Current
27437-107	Antara	fenofibrate	Lupin Pharmaceuticals, Inc.	NDA	Current
27437-107	Antara	fenofibrate	Lupin Pharmaceuticals, Inc.	NDA	Current
27437-108	Antara	fenofibrate	Lupin Pharmaceuticals, Inc.	NDA	Current
27437-108	Antara	fenofibrate	Lupin Pharmaceuticals, Inc.	NDA	Current
27437-108	Antara	fenofibrate	Lupin Pharmaceuticals, Inc.	NDA	Current
27437-109	ANTARA	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	NDA	Current
27437-109	ANTARA	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	NDA	Current
27437-109	ANTARA	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	NDA	Current
27437-109	ANTARA	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	NDA	Current
27437-110	ANTARA	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	NDA	Current
27437-110	ANTARA	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	NDA	Current
27437-110	ANTARA	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	NDA	Current
27437-110	ANTARA	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	NDA	Current
68180-130	Fenofibrate	fenofibrate	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68180-130	Fenofibrate	fenofibrate	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68180-130	Fenofibrate	fenofibrate	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68180-131	Fenofibrate	fenofibrate	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68180-131	Fenofibrate	fenofibrate	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68180-131	Fenofibrate	fenofibrate	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68180-745	FENOFIBRATE	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68180-745	FENOFIBRATE	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68180-745	FENOFIBRATE	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68180-745	FENOFIBRATE	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68180-746	FENOFIBRATE	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68180-746	FENOFIBRATE	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68180-746	FENOFIBRATE	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68180-746	FENOFIBRATE	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83640	SUPPL	2025-10-03
83632	SUPPL	2025-10-02
79274	SUPPL	2024-08-02
79260	SUPPL	2024-07-31
67719	SUPPL	2021-06-07
67704	SUPPL	2021-06-04
58762	SUPPL	2019-05-16
58747	SUPPL	2019-05-16
57819	SUPPL	2019-02-27
57531	SUPPL	2019-02-13
56458	SUPPL	2018-11-15
56402	SUPPL	2018-11-09
54332	SUPPL	2018-05-24
54305	SUPPL	2018-05-22
49757	SUPPL	2017-09-15
49719	SUPPL	2017-09-12
16007	SUPPL	2015-09-04
28396	SUPPL	2013-10-22
16005	SUPPL	2013-10-22
6004	SUPPL	2012-12-26
16006	SUPPL	2012-12-21
37472	SUPPL	2012-03-06
28395	SUPPL	2012-03-05
16004	SUPPL	2008-06-19
28394	SUPPL	2008-06-06
6003	SUPPL	2007-01-23
21781	ORIG	2006-06-08
28393	ORIG	2004-12-06
16003	ORIG	2004-12-03