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SPECTROBID

NDA

BACAMPICILLIN HYDROCHLORIDE | N050520 | PFIZER LABORATORIES DIV PFIZER INC

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 DMFs2 inactive

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

ASTRA LAKEMEDEL ABInactiveBACAMPICILLIN HYDROCHLORIDE

DMF 135901998

KYONGBO PHARMACEUTICAL CO LTDInactiveBACAMPICILLIN HYDROCHLORIDE NON-STERILE, BULK

DMF 176252004

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

Products (2)

Sort:

#001 — 400MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 800MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 12, 1983