Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017426
Company: PERRIGO NEW YORK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESONIDE DESONIDE 0.05% OINTMENT;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
11/01/1974 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/08/2016 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/31/2000 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/08/1997 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.

05/15/1990 SUPPL-13 Labeling

Label is not available on this site.

02/04/1988 SUPPL-12 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/22/1986 SUPPL-11 Labeling

Label is not available on this site.

03/28/1983 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/1983 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/13/1981 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1982 SUPPL-5 Labeling

Label is not available on this site.

12/16/1980 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/01/1980 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/1979 SUPPL-2 Labeling

Label is not available on this site.

04/13/1979 SUPPL-1 Manufacturing (CMC)-Control

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 212473 ALEOR DERMACEUTICALS
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 No AB 208836 HI TECH
DESONIDE DESONIDE 0.05% OINTMENT;TOPICAL Prescription Yes AB 017426 PERRIGO NEW YORK
DESONIDE DESONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 074254 TARO
DESONIDE DESONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 212002 TELIGENT PHARMA INC
DESOWEN DESONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 071425 GALDERMA LABS LP

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