Application 202894

Type: ANDA
Sponsor: GLENMARK 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 43.

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
A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM / TOPICAL			2015-10-30

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 · 43 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
2026-09-14 22:38:34	2026-08	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL		2015-10-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL		2015-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL		2015-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL		2015-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202894-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2015-10-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A202894-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202894-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202894-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202894-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202894-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202894-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202894-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202894-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202894-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202894-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202894-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202894-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202894-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202894-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202894-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202894-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202894-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202894-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202894-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202894-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202894-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202894-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202894-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202894-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202894-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202894-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202894-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202894-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202894-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202894-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202894-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202894-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202894-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202894-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202894-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202894-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202894-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202894-001	AB	1	`cb3db0bc1861…`

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 · 4 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	Direct Rx	bbf26437-c9b4-d8e6-e053-2a95a90a0062	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202894 application number: ANDA202894 ndc (product): 72189-182
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	NuCare Pharmaceuticals,Inc.	5cc511e4-3e7d-70d6-e053-2a91aa0a8044	2024-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202894 application number: ANDA202894 ndc (product): 68071-4134
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Proficient Rx LP	c6e4bf5f-f6d6-489e-9286-c30568c601b7	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202894 application number: ANDA202894 ndc (product): 71205-524
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Glenmark Pharmaceuticals Inc. USA	8dcd24cb-e568-428a-88ac-737d115cc54d	2020-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202894 application number: ANDA202894 ndc (product): 68462-298

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 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2353	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	A-S Medication Solutions	ANDA	Current
50090-2357	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	A-S Medication Solutions	ANDA	Current
53002-9740	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-9740	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-524	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-524	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-524	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-524	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
68071-4134	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4134	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4134	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4401	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4401	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4401	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68462-298	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Glenmark Pharmaceuticals Inc. USA	ANDA	Current
68462-298	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Glenmark Pharmaceuticals Inc. USA	ANDA	Current
68462-298	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Glenmark Pharmaceuticals Inc. USA	ANDA	Current
68788-6990	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6990	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6990	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6990	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6990	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2326	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	REMEDYREPACK INC.	ANDA	Current
70518-2326	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	REMEDYREPACK INC.	ANDA	Current
70518-2326	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	REMEDYREPACK INC.	ANDA	Current
71205-524	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Proficient Rx LP	ANDA	Current
72189-182	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Direct Rx	ANDA	Current