An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075673
Company: TARO

Products on ANDA 075673

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM;TOPICAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075673

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/29/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75673ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/06/2020	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
07/06/2020	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
07/06/2020	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
01/29/2009	SUPPL-10	Labeling		Label is not available on this site.
06/23/2004	SUPPL-9	Labeling		Label is not available on this site.
06/23/2004	SUPPL-6	Labeling		Label is not available on this site.
04/11/2002	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075673

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

CREAM;TOPICAL; EQ 0.05% BASE;1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM;TOPICAL	Prescription	No	AB	076002	ACTAVIS MID ATLANTIC
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM;TOPICAL	Prescription	No	AB	075502	FOUGERA PHARMS
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM;TOPICAL	Prescription	No	AB	202894	GLENMARK PHARMS
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	CREAM;TOPICAL	Prescription	No	AB	075673	TARO

Top