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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074254
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESONIDE DESONIDE 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
08/03/1994 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
01/15/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

01/20/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/11/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/17/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DESONIDE

OINTMENT;TOPICAL; 0.05%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESONIDE DESONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 208836 AKORN
DESONIDE DESONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 212473 ALEMBIC PHARMS
DESONIDE DESONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 210998 ENCUBE ETHICALS
DESONIDE DESONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 075751 FOUGERA PHARMS
DESONIDE DESONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 209996 GLENMARK PHARMS LTD
DESONIDE DESONIDE 0.05% OINTMENT;TOPICAL Prescription Yes AB 017426 PADAGIS US
DESONIDE DESONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 212002 PAI HOLDINGS PHARM
DESONIDE DESONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 074254 TARO
DESOWEN DESONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 071425 GALDERMA LABS LP
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