Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075751
Company: FOUGERA PHARMS

Products on ANDA 075751

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DESONIDE	DESONIDE	0.05%	OINTMENT;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075751

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/12/2001	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75751ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-751_Desonide.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/10/2016	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/23/2001	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 075751

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