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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207280
Company: RISING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETIC ACID ACETIC ACID, GLACIAL 2% SOLUTION/DROPS;OTIC Prescription AT 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
03/09/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

ACETIC ACID

SOLUTION/DROPS;OTIC; 2%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETIC ACID ACETIC ACID, GLACIAL 2% SOLUTION/DROPS;OTIC Prescription No AT 207280 RISING
ACETIC ACID ACETIC ACID, GLACIAL 2% SOLUTION/DROPS;OTIC Prescription No AT 040607 SAPTALIS PHARMS
ACETIC ACID ACETIC ACID, GLACIAL 2% SOLUTION/DROPS;OTIC Prescription No AT 088638 TARO
VOSOL ACETIC ACID, GLACIAL 2% SOLUTION/DROPS;OTIC Prescription No AT 012179 HIKMA
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