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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075224
Company: TARO

Products on ANDA 075224

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075224

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/1998	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75224ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-224_Clobetasol.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/06/2017	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
12/16/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
12/16/2002	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/09/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 075224

CLOBETASOL PROPIONATE

SOLUTION;TOPICAL; 0.05%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	212881	ALEMBIC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	075391	FOUGERA PHARMS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	210190	GLENMARK PHARMS LTD
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	209361	MACLEODS PHARMS LTD
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	206075	NOVEL LABS INC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	211240	QUAGEN
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	211494	SAPTALIS PHARMS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	075224	TARO
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	075363	TARO

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