Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076493
Company: TARO

Products on ANDA 076493

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%	LOTION;TOPICAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076493

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76493ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/23/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
01/29/2009	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076493

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

LOTION;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%	LOTION;TOPICAL	Prescription	No	AB	076516	FOUGERA PHARMS
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	LOTION;TOPICAL	Prescription	No	AB	076493	TARO