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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073638
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PIROXICAM PIROXICAM 20MG CAPSULE;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
01/28/1994 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
03/17/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/07/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/09/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/26/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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