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Abbreviated New Drug Application (ANDA): 078854
Company: ACTAVIS MID ATLANTIC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/07/2011 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078854s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/13/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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 078854 ACTAVIS MID ATLANTIC
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SHAMPOO;TOPICAL Prescription No AB 209871 AKORN
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SHAMPOO;TOPICAL Prescription No AB 213290 ALEOR DERMACEUTICALS
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 PHARMS
CLOBEX CLOBETASOL PROPIONATE 0.05% SHAMPOO;TOPICAL Prescription Yes AB 021644 GALDERMA LABS
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