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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017010
Company: PADAGIS US

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESONIDE DESONIDE 0.05% CREAM;TOPICAL Prescription AB Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/04/1972 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/017010Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2016 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
05/15/2014 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
08/31/2000 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
03/17/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
09/09/1996 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
06/12/1995 SUPPL-14 Labeling

Label is not available on this site.
03/08/1991 SUPPL-13 Labeling

Label is not available on this site.
01/05/1983 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
09/16/1982 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
12/06/1982 SUPPL-9 Labeling

Label is not available on this site.
12/16/1980 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.
05/01/1980 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
04/19/1979 SUPPL-6 Labeling

Label is not available on this site.
04/17/1979 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
02/12/1976 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.
04/10/1974 SUPPL-2

Label is not available on this site.

DESONIDE

CREAM;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% CREAM;TOPICAL Prescription No AB 214396 ALEMBIC
DESONIDE DESONIDE 0.05% CREAM;TOPICAL Prescription No AB 210198 CADILA
DESONIDE DESONIDE 0.05% CREAM;TOPICAL Prescription No AB 074027 COSETTE
DESONIDE DESONIDE 0.05% CREAM;TOPICAL Prescription No AB 209729 GLENMARK SPECLT
DESONIDE DESONIDE 0.05% CREAM;TOPICAL Prescription Yes AB 017010 PADAGIS US
DESONIDE DESONIDE 0.05% CREAM;TOPICAL Prescription No AB 073548 TARO
DESOWEN DESONIDE 0.05% CREAM;TOPICAL Prescription No AB 019048 GALDERMA LABS LP
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