Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074221
Company: HI TECH PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EMBELINE CLOBETASOL 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
03/31/1995 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
02/13/2019 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

06/27/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/05/1998 SUPPL-4 Labeling

Label is not available on this site.

11/05/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/05/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/05/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

EMBELINE

OINTMENT;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% OINTMENT;TOPICAL Prescription No AB 074089 ACP NIMBLE
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 211800 ALEOR DERMACEUTICALS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 209701 CHEMO RESEARCH SL
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 074407 FOUGERA PHARMS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 208933 GLENMARK PHARMS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 075057 MYLAN
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 208841 NOVEL LABS INC
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 074248 TARO
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 208589 TELIGENT PHARMA INC
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 210199 ZYDUS PHARMS
EMBELINE CLOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 074221 HI TECH PHARMA

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