An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074118
Company: SOLIS PHARMS

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-Medication Guide, Labeling-Package Insert		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	SOLIS PHARMS
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	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	SOLIS PHARMS
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	205585	ZYDUS LIFESCIENCES

Top