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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075027
Company: PADAGIS US

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/31/1997 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/28/2007 SUPPL-5 Labeling

Label is not available on this site.
12/20/2000 SUPPL-4 Labeling

Label is not available on this site.
12/20/2000 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/24/2000 SUPPL-2 Labeling

Label is not available on this site.

CLOBETASOL PROPIONATE

GEL;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% GEL;TOPICAL Prescription No AB 075368 FOUGERA PHARMS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% GEL;TOPICAL Prescription No AB 075027 PADAGIS US
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% GEL;TOPICAL Prescription No AB 075279 TARO
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