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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074118
Company: NOSTRUM LABS INC

Products on ANDA 074118

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PIROXICAM	PIROXICAM	20MG	CAPSULE;ORAL	Prescription	AB	No	No
PIROXICAM	PIROXICAM	10MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074118

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/1993	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
12/23/2019	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/23/2019	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
06/30/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
06/30/2015	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/30/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/14/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
10/21/2011	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 074118

PIROXICAM

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

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

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