Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040609
Company: VINTAGE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE AND ACETIC ACID ACETIC ACID, GLACIAL; HYDROCORTISONE 2%;1% 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
02/06/2006 ORIG-1 Approval

Label is not available on this site.

HYDROCORTISONE AND ACETIC ACID

SOLUTION/DROPS;OTIC; 2%;1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCORTISONE AND ACETIC ACID ACETIC ACID, GLACIAL; HYDROCORTISONE 2%;1% SOLUTION/DROPS;OTIC Prescription No AT 088759 TARO PHARM INDS LTD
HYDROCORTISONE AND ACETIC ACID ACETIC ACID, GLACIAL; HYDROCORTISONE 2%;1% SOLUTION/DROPS;OTIC Prescription No AT 040609 VINTAGE
VOSOL HC ACETIC ACID, GLACIAL; HYDROCORTISONE 2%;1% SOLUTION/DROPS;OTIC Prescription Yes AT 012770 HI TECH PHARMA

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