Application 075502

Type: ANDA
Sponsor: FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	CREAM;TOPICAL	EQ 0.05% BASE;1%	No	No

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

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
A075502-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2001-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075502-001	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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	A075502-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2001-06-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075502-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2001-06-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075502-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2001-06-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075502-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2001-06-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A075502-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075502-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075502-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075502-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075502-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075502-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075502-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075502-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075502-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075502-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075502-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075502-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075502-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075502-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075502-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075502-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075502-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075502-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075502-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075502-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075502-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075502-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075502-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075502-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075502-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075502-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075502-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075502-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075502-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075502-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075502-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075502-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075502-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075502-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075502-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075502-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075502-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075502-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075502-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075502-001	AB	1	`3a93d1ddd44b…`

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
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	55db730a-df6d-4950-9c26-91b06bdcef36	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075502 application number: ANDA075502 ndc (product): 0168-0258

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0258	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current
0168-0258	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current
0168-0258	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current
50436-4546	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Unit Dose Services	ANDA	Current
55700-061	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
70518-0339	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	REMEDYREPACK INC.	ANDA	Current
70518-0339	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	REMEDYREPACK INC.	ANDA	Current
70518-0339	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	REMEDYREPACK INC.	ANDA	Current
70518-0339	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	REMEDYREPACK INC.	ANDA	Current
70518-0339	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	REMEDYREPACK INC.	ANDA	Current
70518-0339	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	REMEDYREPACK INC.	ANDA	Current
70518-0339	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	REMEDYREPACK INC.	ANDA	Current
70518-0339	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	REMEDYREPACK INC.	ANDA	Current
70786-0258	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Unit Dose Services	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30916	ORIG	2001-06-05
22479	ORIG	2001-06-05