Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076994
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOBETASOL PROPIONATE HALOBETASOL PROPIONATE 0.05% OINTMENT;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/2004/076994ltr.pdf

HALOBETASOL PROPIONATE

OINTMENT;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% OINTMENT;TOPICAL Prescription No AB 077109 ACP NIMBLE
HALOBETASOL PROPIONATE HALOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 077721 ACP NIMBLE
HALOBETASOL PROPIONATE HALOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 076872 PERRIGO ISRAEL
HALOBETASOL PROPIONATE HALOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 076994 TARO
HALOBETASOL PROPIONATE HALOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 209978 TELIGENT PHARMA INC
ULTRAVATE HALOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription Yes AB 019968 SUN PHARM INDS INC

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