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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090898
Company: PADAGIS US

Products on ANDA 090898

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090898

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/16/2011	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/090898Orig1s000Approv.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2019	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/06/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
11/17/2017	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/17/2017	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090898

CLOBETASOL PROPIONATE

SPRAY;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%	SPRAY;TOPICAL	Prescription	No	AT	211191	ALEMBIC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SPRAY;TOPICAL	Prescription	No	AT	209004	GLENMARK PHARMS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SPRAY;TOPICAL	Prescription	No	AT	208125	LUPIN LTD
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SPRAY;TOPICAL	Prescription	No	AT	090898	PADAGIS US
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SPRAY;TOPICAL	Prescription	No	AT	208842	TARO
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SPRAY;TOPICAL	Prescription	No	AT	206378	ZYDUS PHARMS
CLOBEX	CLOBETASOL PROPIONATE	0.05%	SPRAY;TOPICAL	Prescription	Yes	AT	021835	GALDERMA LABS LP

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