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PERMAPEN

NDA

PENICILLIN G BENZATHINE | N060014 | CASPER PHARMA LLC

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 Chain3 active DMFs4 inactive

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

SANDOZ GMBHPENICILLIN G BENZATHINE (STERILE)

DMF 132941998

FRESENIUS KABI IPSUM SRLPENICILLIN G BENZATHINE LECITHIN COATED STERILE

DMF 402972025

APITORIA PHARMA PRIVATE LTDPENICILLIN G BENZATHINE (LECITHIN COATED) STERILE

DMF 406772025

PFIZER INCInactivePENICILLIN G BENZATHINE

DMF 133181998

WYETH-AYERST LABORATORIESInactivePENICILLIN G BENZATHINE

DMF 133281998

BRISTOL EUROPE SPAInactivePENICILLIN G BENZATHINE

DMF 136551998

GIST-BROCADES NV PHARMACEUTICALSInactivePENICILLIN G BENZATHINE

DMF 137321998

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

Products (1)

#001 — 600,000 UNITS/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.