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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203981
Company: CALL INC

Products on ANDA 203981

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADAPALENE	ADAPALENE	0.1%	SOLUTION;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203981

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/23/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 203981

ADAPALENE

SOLUTION;TOPICAL; 0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ADAPALENE	ADAPALENE	0.1%	SOLUTION;TOPICAL	Prescription	No	AB	203981	CALL INC
ADAPALENE	ADAPALENE	0.1%	SOLUTION;TOPICAL	Prescription	No	AB	204593	CALL INC

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