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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077001
Company: FOUGERA PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOBETASOL PROPIONATE HALOBETASOL PROPIONATE 0.05% CREAM;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
12/16/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/077001ltr.pdf

HALOBETASOL PROPIONATE

CREAM;TOPICAL; 0.05%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HALOBETASOL PROPIONATE HALOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB 078162 COSETTE
HALOBETASOL PROPIONATE HALOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB 077001 FOUGERA PHARMS
HALOBETASOL PROPIONATE HALOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB 077123 PADAGIS ISRAEL
HALOBETASOL PROPIONATE HALOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB 077227 TARO
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