Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090974
Company: PADAGIS ISRAEL

Products on ANDA 090974

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090974

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/09/2012	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090974

CLOBETASOL PROPIONATE

SHAMPOO;TOPICAL; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SHAMPOO;TOPICAL	Prescription	No	AB	213290	ALEMBIC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SHAMPOO;TOPICAL	Prescription	No	AB	214895	AMNEAL
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SHAMPOO;TOPICAL	Prescription	No	AB	090974	PADAGIS ISRAEL
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SHAMPOO;TOPICAL	Prescription	No	AB	214867	TARO
CLOBEX	CLOBETASOL PROPIONATE	0.05%	SHAMPOO;TOPICAL	Prescription	Yes	AB	021644	GALDERMA LABS