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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088638
Company: TARO
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
09/06/1984 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
04/30/2001 SUPPL-17 Labeling

Label is not available on this site.

11/22/1999 SUPPL-16 Labeling

Label is not available on this site.

04/06/1993 SUPPL-15 Labeling

Label is not available on this site.

03/15/1993 SUPPL-14 Labeling

Label is not available on this site.

12/20/1989 SUPPL-13 Labeling

Label is not available on this site.

08/31/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/29/1988 SUPPL-11 Labeling

Label is not available on this site.

08/11/1988 SUPPL-10 Labeling

Label is not available on this site.

03/01/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/15/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/04/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/30/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/30/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/17/1984 SUPPL-1 Manufacturing (CMC)

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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