Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077763
Company: PERRIGO ISRAEL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM;TOPICAL Prescription AB1 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
03/10/2008 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077763s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/14/2019 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

11/14/2019 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

CLOBETASOL PROPIONATE

AEROSOL, FOAM;TOPICAL; 0.05%
TE Code = AB1

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 AB1 210809 GLENMARK PHARMS LTD
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM;TOPICAL Prescription No AB1 206805 INGENUS PHARMS LLC
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM;TOPICAL Prescription No AB1 077763 PERRIGO ISRAEL
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM;TOPICAL Prescription No AB1 208779 TARO
OLUX CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM;TOPICAL Prescription Yes AB1 021142 MYLAN

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