Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089420
Company: SCHWARZ PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZDONE ASPIRIN; HYDROCODONE BITARTRATE 500MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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
01/25/1988 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
09/14/1999 SUPPL-26 Labeling

Label is not available on this site.

06/22/1999 SUPPL-25 Labeling

Label is not available on this site.

11/29/1999 SUPPL-24 Manufacturing (CMC)-Facility

Label is not available on this site.

02/23/1995 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/23/1995 SUPPL-20 Labeling

Label is not available on this site.

02/23/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/30/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/30/1993 SUPPL-17 Labeling

Label is not available on this site.

04/30/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/29/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/30/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/22/1991 SUPPL-11 Labeling

Label is not available on this site.

04/16/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/29/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/06/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/06/1990 SUPPL-2 Labeling

Label is not available on this site.

06/15/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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