Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017426
Company: PADAGIS US

Products on NDA 017426

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017426

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.

Therapeutic Equivalents for NDA 017426

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	ALEMBIC
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	074254	TARO
DESOWEN	DESONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	071425	GALDERMA LABS LP