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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206152
Company: MICRO LABS

Products on ANDA 206152

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 206152

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/03/2023	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/03/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
10/07/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206152

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

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