Application 076002

Type: ANDA
Sponsor: ACTAVIS MID ATLANTIC

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 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
A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB		2002-08-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076002-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076002-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	CREAM / TOPICAL	AB	2002-08-02	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076002-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076002-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076002-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076002-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076002-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076002-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076002-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076002-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076002-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076002-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076002-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076002-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076002-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076002-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076002-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076002-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076002-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076002-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076002-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076002-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076002-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076002-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076002-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076002-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076002-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076002-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076002-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076002-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076002-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076002-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076002-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076002-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076002-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076002-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076002-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076002-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076002-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076002-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076002-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076002-001	AB	1	`e64feba35796…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole/Betameth	CLOTRIMAZOLE/BETAMETH	Direct_Rx	08901233-7d36-e5d9-e063-6394a90af33d	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076002 application number: ANDA076002
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Bryant Ranch Prepack	153fed41-6662-4ca9-802f-84b44dcb65e9	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076002 application number: ANDA076002 ndc (product): 63629-8758
DermacinRx Therazole Pak	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, ZINC OXIDE	PureTek Corporation	c47f8a9c-9c86-4068-814e-05ab2090d19e	2024-12-13	Warnings, Adverse reactions	Exact identifier ndc (product): 59088-893
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Actavis Pharma, Inc.	a6ac4020-2c67-426a-8289-7e54ce43d0c9	2024-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076002 application number: ANDA076002 ndc (product): 0472-0379
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	5ca32ede-b546-4b65-90d6-c69add760522	2023-09-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076002 application number: ANDA076002
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Proficient Rx LP	3d235926-6f17-4aa5-be82-7f1b4357e247	2022-06-01	Adverse reactions	Exact identifier application applno (ANDA): 076002 application number: ANDA076002 ndc (product): 63187-095

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0472-0379	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Actavis Pharma, Inc.	ANDA	Current
0472-0379	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Actavis Pharma, Inc.	ANDA	Current
0472-0379	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Actavis Pharma, Inc.	ANDA	Current
50090-1558	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	A-S Medication Solutions	ANDA	Current
53002-9741	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	RPK Pharmaceuticals, Inc.	ANDA	Current
59088-893	DermacinRx Therazole Pak	clotrimazole and betamethasone dipropionate, zinc oxide	PureTek Corporation	ANDA	Current
63187-095	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Proficient Rx LP	ANDA	Current
63187-095	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Proficient Rx LP	ANDA	Current
63187-095	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Proficient Rx LP	ANDA	Current
63187-095	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Proficient Rx LP	ANDA	Current
63187-095	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Proficient Rx LP	ANDA	Current
63629-8758	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Bryant Ranch Prepack	ANDA	Current
63629-8758	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Bryant Ranch Prepack	ANDA	Current
63629-8758	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Bryant Ranch Prepack	ANDA	Current
68071-1593	clotrimazole and betamethasone dipropionate	clotrimazole and betamethasone dipropionate	NuCare Pharamceuticals,Inc.	ANDA	Current
68071-1734	clotrimazole and betamethasone dipropionate	clotrimazole and betamethasone dipropionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4080	clotrimazole and betamethasone dipropionate	clotrimazole and betamethasone dipropionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-1249	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	REMEDYREPACK INC.	ANDA	Current
70518-1249	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	REMEDYREPACK INC.	ANDA	Current