Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075430
Company: FOUGERA PHARMS

Products on ANDA 075430

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOBETASOL PROPIONATE (EMOLLIENT)	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	AB2	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075430

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/26/1999	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75430ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75-430_clobetasol.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/21/2018	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
03/16/2007	SUPPL-4	Labeling		Label is not available on this site.
06/14/1999	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075430

CLOBETASOL PROPIONATE (EMOLLIENT)

CREAM;TOPICAL; 0.05%
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOBETASOL PROPIONATE (EMOLLIENT)	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB2	209411	BEACH PRODS
CLOBETASOL PROPIONATE (EMOLLIENT)	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB2	075430	FOUGERA PHARMS
CLOBETASOL PROPIONATE (EMOLLIENT)	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB2	075633	SUN PHARMA CANADA