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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074131
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription AB No No
PIROXICAM PIROXICAM 20MG CAPSULE;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
12/11/1992 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
02/08/2022 SUPPL-28 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.

12/23/2019 SUPPL-24 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/23/2019 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/23/2019 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

11/29/2010 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

01/08/2008 SUPPL-16 Labeling

Label is not available on this site.

04/04/2006 SUPPL-15 Labeling

Label is not available on this site.

03/02/2006 SUPPL-14 Labeling

Label is not available on this site.

12/02/1999 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

12/02/1999 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

02/12/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/12/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/13/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/11/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

PIROXICAM

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FELDENE PIROXICAM 10MG CAPSULE;ORAL Prescription Yes AB 018147 PFIZER
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 205585 CADILA
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 207938 FLAMINGO PHARMS
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 209256 HIKMA
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 206152 MICRO LABS
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 074118 NOSTRUM LABS INC
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 206136 STRIDES PHARMA
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 210347 STRIDES PHARMA
PIROXICAM PIROXICAM 10MG CAPSULE;ORAL Prescription No AB 074131 TEVA

CAPSULE;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FELDENE PIROXICAM 20MG CAPSULE;ORAL Prescription Yes AB 018147 PFIZER
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 205585 CADILA
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 207938 FLAMINGO PHARMS
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 209256 HIKMA
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 206152 MICRO LABS
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 074118 NOSTRUM LABS INC
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 206136 STRIDES PHARMA
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 210347 STRIDES PHARMA
PIROXICAM PIROXICAM 20MG CAPSULE;ORAL Prescription No AB 074131 TEVA
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