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PIROXICAM

ANDA

PIROXICAM | A073637 | TEVA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Mutual Pharmaceutical Company, Inc. - Citizen Petition FDA-2013-P-0666 · 3 docket documents Mutual Pharmaceutical Company, Inc. filed this citizen petition under Section 505(j)(2)(C) requesting permission to file an ANDA for Piroxicam Capsules 5mg, a lower-strength version of its already-approved 10mg and 20mg piroxicam capsules (ANDA 73-536), with a bioequivalence waiver based on dose pro	Other	2013-06-17	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain5 active DMFs12 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

DIPHARMA FRANCIS SRLPIROXICAM

DMF 74721988

ARCH PHARMALABS LTDPIROXICAM USP

DMF 91181991

OLON SPAPIROXICAM

DMF 269612013

UNICHEM LABORATORIES LTDPIROXICAM USP

DMF 280602014

APEX HEALTHCARE LTDPIROXICAM USP

DMF 368412022

FABBRICA ITALIANA SINTETICI SPAInactivePIROXICAM

DMF 71301987

WOCKHARDT LTDInactivePIROXICAM

DMF 74471988

MOEHS SA DIV SANOFInactivePIROXICAM

DMF 74731988

EGIS PHARMACEUTICALS PRIVATE LTDInactivePIROXICAM

DMF 75851988

SIBEFAT SPAInactivePIROXICAM

DMF 76601988

ESTEVE QUIMICA SAInactivePIROXICAM

DMF 76971988

KRKA PHARMACEUTICAL AND CHEMICAL WORKSInactivePIROXICAM

DMF 80551989

NANTONG PHARMACEUTICAL FACTORYInactivePIROXICAM

DMF 81841989

MEDICHEM SAInactivePIROXICAM

DMF 82311989

SUMIKA FINE CHEMICALS CO LTDInactivePIROXICAM

DMF 83531989

CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTDInactivePIROXICAM

DMF 106951993

RAMDEV CHEMICAL PVT LTDInactivePIROXICAM USP

DMF 319012017

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 10MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 28, 1994

No patent or exclusivity listings for this strength.