Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 081319
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PYRAZINAMIDE PYRAZINAMIDE 500MG TABLET;ORAL Prescription AB 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
06/30/1992 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
08/13/2002 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.

05/29/2001 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.

05/29/2001 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/31/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/10/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/10/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/10/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/08/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/16/1994 SUPPL-11 Labeling

Label is not available on this site.

09/16/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/16/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/16/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/28/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/28/1994 SUPPL-6 Labeling

Label is not available on this site.

02/28/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/28/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/28/1994 SUPPL-3 Labeling

Label is not available on this site.

02/28/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/16/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

PYRAZINAMIDE

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PYRAZINAMIDE PYRAZINAMIDE 500MG TABLET;ORAL Prescription No AB 081319 AKORN
PYRAZINAMIDE PYRAZINAMIDE 500MG TABLET;ORAL Prescription No AB 080157 DAVA PHARMS INC

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