Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201402
Company: PADAGIS ISRAEL

Products on ANDA 201402

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM;TOPICAL	Prescription	AB2	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201402

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/14/2012	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201402Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2019	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
09/06/2019	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201402

CLOBETASOL PROPIONATE

AEROSOL, FOAM;TOPICAL; 0.05%
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB2	211450	GLENMARK PHARMS LTD
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB2	201402	PADAGIS ISRAEL
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB2	208563	TARO