Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074131
Company: TEVA

Products on ANDA 074131

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074131

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
10/10/2023	SUPPL-31	Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.
02/08/2022	SUPPL-28	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/23/2019	SUPPL-24	Labeling-Medication Guide, Labeling-Package Insert		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.

Therapeutic Equivalents for ANDA 074131

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	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
PIROXICAM	PIROXICAM	10MG	CAPSULE;ORAL	Prescription	No	AB	208340	UNICHEM
PIROXICAM	PIROXICAM	10MG	CAPSULE;ORAL	Prescription	No	AB	205585	ZYDUS LIFESCIENCES

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	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
PIROXICAM	PIROXICAM	20MG	CAPSULE;ORAL	Prescription	No	AB	208340	UNICHEM
PIROXICAM	PIROXICAM	20MG	CAPSULE;ORAL	Prescription	No	AB	205585	ZYDUS LIFESCIENCES