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AUREOMYCIN

NDA

CHLORTETRACYCLINE HYDROCHLORIDE | N050404 | LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO

1 strength0 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 Chain1 active DMF9 inactive

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

FUJIAN FUKANG PHARMACEUTICAL CO LTDCHLORTETRACYCLINE HYDROCHLORIDE

DMF 137061998

PIERREL AMERICA INCInactiveCHLORTETRACYCLINE HYDROCHLORIDE

DMF 133041998

ANGUS BIOTECH INCInactiveCHLORTETRACYCLINE HYDROCHLORIDE

DMF 133091998

LEDERLE LABORATORIESInactiveCHLORTETRACYCLINE HYDROCHLORIDE

DMF 133471998

FARMITALIA CARLO ERBA SPAInactiveCHLORTETRACYCLINE HYDROCHLORIDE

DMF 133531998

COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARLInactiveCHLORTETRACYCLINE HYDROCHLORIDE

DMF 133911998

DIAMOND SHAMROCKInactiveCHLORTETRACYCLINE HYDROCHLORIDE

DMF 134111998

ISFInactiveCHLORTETRACYCLINE HYDROCHLORIDE

DMF 134201998

LEDERLE LABORATORIESInactiveCHLORTETRACYCLINE HYDROCHLORIDE

DMF 134951998

LEDERLE LABORATORIESInactiveCHLORTETRACYCLINE HYDROCHLORIDE

DMF 136061998

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

Products (1)

#001 — 1%

0 patents0 exclusivities▴

OINTMENT;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.