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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074460
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Discontinued None No No
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
09/29/1995 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
04/12/2001 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

03/21/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

07/08/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/16/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/16/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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