Application 075528

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOMIPHENE CITRATE	CLOMIPHENE CITRATE	TABLET;ORAL	50MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075528-001	CLOMID	CLOMIPHENE CITRATE	50MG	TABLET / ORAL	AB	RS	1999-08-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075528-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A075528-001	CLOMID	50MG	TABLET / ORAL	AB	RS	1999-08-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL	AB	RS	1999-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL	AB	RS	1999-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL	AB	RS	1999-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL	AB	RS	1999-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL	AB	RS	1999-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL	AB	RS	1999-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL	AB	RS	1999-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075528-001	CLOMIPHENE CITRATE	50MG	TABLET / ORAL		RS	1999-08-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075528-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075528-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075528-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075528-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075528-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075528-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075528-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075528-001	AB	1	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075528-001	AB	1	`a50c72e98297…`

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
Clomiphene Citrate	CLOMIPHENE CITRATE	Cosette Pharmaceuticals NC Laboratories, LLC	72719958-7454-4c54-9bb4-f3054d0c5d82	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075528 application number: ANDA075528
Clomid	CLOMIPHENE CITRATE	Cosette Pharmaceuticals, Inc.	2ca373c1-4dba-4126-8616-5c533d606fe5	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075528 application number: ANDA075528 ndc (product): 0713-0885
CLOMID	CLOMIPHENE CITRATE	A-S Medication Solutions	f15e9918-6001-4150-bd54-1364a6febcb8	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075528 application number: ANDA075528

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
0713-0885	Clomid	Clomiphene Citrate	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0885	Clomid	Clomiphene Citrate	Cosette Pharmaceuticals, Inc.	ANDA	Current
21695-114	Clomiphene Citrate	Clomiphene Citrate	Rebel Distributors Corp	ANDA	Current
49884-701	Clomiphene Citrate	Clomiphene Citrate	Par Pharmaceutical, Inc.	ANDA	Current
49884-701	Clomiphene Citrate	Clomiphene Citrate	Par Pharmaceutical, Inc.	ANDA	Current
49884-701	Clomiphene Citrate	Clomiphene Citrate	Par Pharmaceutical, Inc.	ANDA	Current
49884-701	Clomiphene Citrate	Clomiphene Citrate	Par Pharmaceutical, Inc.	ANDA	Current
50090-0678	Clomiphene Citrate	Clomiphene Citrate	A-S Medication Solutions	ANDA	Current
50090-0678	Clomiphene Citrate	Clomiphene Citrate	A-S Medication Solutions	ANDA	Current
50090-0678	Clomiphene Citrate	Clomiphene Citrate	A-S Medication Solutions	ANDA	Current
61919-375	CLOMIPHENE CITRATE	CLOMIPHENE CITRATE	DIRECTRX	ANDA	Current
63629-2165	Clomiphene Citrate	Clomiphene Citrate	Bryant Ranch Prepack	ANDA	Current
63629-2165	Clomiphene Citrate	Clomiphene Citrate	Bryant Ranch Prepack	ANDA	Current
63629-2165	Clomiphene Citrate	Clomiphene Citrate	Bryant Ranch Prepack	ANDA	Current
63629-5302	Clomiphene Citrate	Clomiphene Citrate	Bryant Ranch Prepack	ANDA	Current
63629-5302	Clomiphene Citrate	Clomiphene Citrate	Bryant Ranch Prepack	ANDA	Current
63629-5302	Clomiphene Citrate	Clomiphene Citrate	Bryant Ranch Prepack	ANDA	Current
63629-5302	Clomiphene Citrate	Clomiphene Citrate	Bryant Ranch Prepack	ANDA	Current
63629-5302	Clomiphene Citrate	Clomiphene Citrate	Bryant Ranch Prepack	ANDA	Current
63629-5302	Clomiphene Citrate	Clomiphene Citrate	Bryant Ranch Prepack	ANDA	Current
63629-5302	Clomiphene Citrate	Clomiphene Citrate	Bryant Ranch Prepack	ANDA	Current
63629-5302	Clomiphene Citrate	Clomiphene Citrate	Bryant Ranch Prepack	ANDA	Current
63629-9276	Clomiphene Citrate	Clomiphene Citrate	Bryant Ranch Prepack	ANDA	Current
68071-2166	Clomiphene Citrate	Clomiphene Citrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-2638	Clomiphene Citrate	Clomiphene Citrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4676	Clomiphene Citrate	Clomiphene Citrate	NuCare Pharmaceuticals,In	ANDA	Current
68071-4676	Clomiphene Citrate	Clomiphene Citrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4676	Clomiphene Citrate	Clomiphene Citrate	NuCare Pharmaceuticals,Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30925	ORIG	1999-08-30