Application 201748

Type: ANDA
Sponsor: SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENOFIBRATE	FENOFIBRATE	CAPSULE;ORAL	43MG	No	No
002	FENOFIBRATE	FENOFIBRATE	CAPSULE;ORAL	130MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A201748-001	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	43MG	CAPSULE / ORAL			2014-10-31
A201748-002	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	130MG	CAPSULE / ORAL			2014-10-31

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 · 88 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
2026-10-15 13:18:30	2026-09	A201748-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL		2014-10-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201748-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL		2014-10-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A201748-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL		2014-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201748-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL		2014-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201748-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL		2014-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201748-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL		2014-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201748-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL		2014-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201748-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL		2014-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201748-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL		2014-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201748-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL		2014-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`4b0b4de00fa7…`

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
2025-08-23 18:47 UTC	2025-08	A201748-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201748-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201748-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201748-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201748-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201748-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201748-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201748-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201748-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201748-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201748-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201748-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201748-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201748-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201748-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201748-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201748-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201748-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201748-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201748-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201748-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201748-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201748-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201748-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201748-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201748-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201748-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201748-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201748-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201748-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201748-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201748-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201748-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201748-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201748-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201748-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201748-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201748-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201748-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201748-002	AB	1	`5aa47cf7b7d7…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	PD-Rx Pharmaceuticals, Inc.	2f5cee5c-ec55-4e9b-9d54-e7f2f052130e	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201748 application number: ANDA201748

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-292	Fenofibrate	Fenofibrate	AvKARE, Inc.	ANDA	Current
42291-292	Fenofibrate	Fenofibrate	AvKARE	ANDA	Current
63304-443	Fenofibrate	Fenofibrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-443	Fenofibrate	Fenofibrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-443	Fenofibrate	Fenofibrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-443	Fenofibrate	Fenofibrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-444	Fenofibrate	Fenofibrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-444	Fenofibrate	Fenofibrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-444	Fenofibrate	Fenofibrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-444	Fenofibrate	Fenofibrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current