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TETREX

NDA

TETRACYCLINE PHOSPHATE COMPLEX | N050212 | BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain0 active DMFs6 inactive

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

FERMIC SA DE CVInactiveTETRACYCLINE PHOSPHATE COMPLEX

DMF 134621998

ANTIBIOTICOS INCInactiveTETRACYCLINE PHOSPHATE COMPLEX

DMF 135201998

BRISTOLInactiveTETRACYCLINE PHOSPHATE COMPLEX

DMF 135381998

CHEMIBIOTIC IRELAND LTDInactiveTETRACYCLINE PHOSPHATE

DMF 135721998

ANSA ANTIBIOTIK VE ILAC HAMMADDERI SANAYI A SInactiveTETRACYCLINE PHOSPHATE COMPLEX

DMF 136671998

COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARLInactiveTETRACYCLINE PHOSPHATE

DMF 142431999

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

Products (2)

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#002 — EQ 250MG HYDROCHLORIDE

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#003 — EQ 500MG HYDROCHLORIDE

0 patents0 exclusivities▾

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