Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012179
Company: HI TECH PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VOSOL 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
05/17/1960 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/16/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/29/1997 SUPPL-18 Labeling

Label is not available on this site.

12/21/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/29/1988 SUPPL-15 Labeling

Label is not available on this site.

08/26/1986 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/24/1985 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/03/1987 SUPPL-12 Labeling

Label is not available on this site.

06/06/1984 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/06/1984 SUPPL-8 Labeling

Label is not available on this site.

06/02/1975 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1974 SUPPL-5

Label is not available on this site.

VOSOL

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 ANDA REPOSITORY
ACETIC ACID ACETIC ACID, GLACIAL 2% SOLUTION/DROPS;OTIC Prescription No AT 040607 MLV
ACETIC ACID ACETIC ACID, GLACIAL 2% SOLUTION/DROPS;OTIC Prescription No AT 088638 TARO
ACETIC ACID ACETIC ACID, GLACIAL 2% SOLUTION/DROPS;OTIC Prescription No AT 040166 WOCKHARDT BIO AG
VOSOL ACETIC ACID, GLACIAL 2% SOLUTION/DROPS;OTIC Prescription No AT 012179 HI TECH PHARMA

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