Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212842
Company: SOLARIS PHARMA CORP

Products on ANDA 212842

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL;TOPICAL	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212842

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/13/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212842

CLINDAMYCIN PHOSPHATE

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