Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075860
Company: FOUGERA PHARMS

Products on ANDA 075860

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075860

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/19/2002	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75860.ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/23/2003	SUPPL-5	Labeling		Label is not available on this site.
12/03/2003	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075860

DESONIDE

LOTION;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%	LOTION;TOPICAL	Prescription	No	AB	213632	ALEMBIC
DESONIDE	DESONIDE	0.05%	LOTION;TOPICAL	Prescription	No	AB	075860	FOUGERA PHARMS
DESONIDE	DESONIDE	0.05%	LOTION;TOPICAL	Prescription	No	AB	209494	GLENMARK PHARMS
DESONIDE	DESONIDE	0.05%	LOTION;TOPICAL	Prescription	No	AB	202161	TARO
DESOWEN	DESONIDE	0.05%	LOTION;TOPICAL	Prescription	No	AB	072354	GALDERMA LABS LP