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PHENYLBUTAZONE

ANDA

PHENYLBUTAZONE | A084339 | FOSUN PHARMA USA INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Phoenix Scientific, Inc. FDA-2000-P-0756 · 3 docket documents Phoenix Scientific, Inc. filed this suitability petition under FFDCA Section 512(n)(3) requesting permission to file an Abbreviated New Animal Drug Application (ANADA) for Phenylbutazone Powder, a granulated powder formulation for oral use in horses that differs only in physical form from the approv	Other	2017-05-11	Open	Phoenix Scientific, Inc.

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

API Supply Chain0 active DMFs5 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

AMSA ANONIMA MEDICINALI SINTETICI AND AFFINI SPAInactivePHENYLBUTAZONE

DMF 15481970

INQUIME INDS QUIMECA ESTENE SAInactivePHENYLBUTAZONE USP

DMF 17021970

RP SCHERER CORPInactivePHENYLBUTAZONE CAPSULES 100MG

DMF 19251972

NAPP CHEMICALS INCInactivePHENYLBUTAZONE

DMF 24231975

MEDIMPEX NORTHAMERICA INCInactivePHENYLBUTAZONE

DMF 25471975

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

Products (1)

#001 — 100MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.