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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204593
Company: CALL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADAPALENE ADAPALENE 0.1% SOLUTION;TOPICAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/05/2016 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/11/2017 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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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