Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050782
Company: BAUSCH

Products on NDA 050782

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAGEL	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	AB2	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050782

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50782lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50782LTR-LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-782_Clindagel.html

Labels for NDA 050782

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/27/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50782lbl.pdf

Therapeutic Equivalents for NDA 050782

CLINDAGEL

GEL;TOPICAL; EQ 1% BASE
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLINDAGEL	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	Yes	AB2	050782	BAUSCH
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB2	214668	AMNEAL
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	No	AB2	212842	SOLARIS PHARMA CORP