Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087143
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETASOL HC 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
01/13/1982 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
12/29/2000 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/07/1998 SUPPL-19 Labeling

Label is not available on this site.

10/26/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/17/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/06/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/13/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/04/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/09/1990 SUPPL-7 Labeling

Label is not available on this site.

12/15/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/17/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/13/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/08/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

ACETASOL HC

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETASOL HC ACETIC ACID, GLACIAL; HYDROCORTISONE 2%;1% SOLUTION/DROPS;OTIC Prescription No AT 087143 ACTAVIS MID ATLANTIC
HYDROCORTISONE AND ACETIC ACID ACETIC ACID, GLACIAL; HYDROCORTISONE 2%;1% SOLUTION/DROPS;OTIC Prescription No AT 088759 TARO
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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