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NDA

NEOMYCIN SULFATE | N050285 | PHARMACIA AND UPJOHN 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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Mechanical Bowel Prep Randomized Study NCT04931173	N/A	Not Yet Recruiting	Mount Sinai Hospital, Canada	1,062	2026-09 → 2028-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain3 active DMFs10 inactive

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

PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INCNEOMYCIN SULFATE USP

DMF 133781998

HUASHU PHARMACEUTICAL CORPNEOMYCIN SULFATE

DMF 173822004

YICHANG SANXIA PHARMACEUTICAL CO LTDNEOMYCIN SULFATE AND NEOMYCIN SULFATE MICRONIZED

DMF 320912017

SB PENICK AND COInactiveNEOMYCIN SULFATE USP

DMF 1101953

PFIZER INCInactiveNEOMYCIN SULFATE CAPS (THIS DMF CHANGED TO NDA 9-579)

DMF 1241953

APOTHEKERNES LABORATORIUM ASInactiveNEOMYCIN SULFATE

DMF 2421940

UPJOHN COInactiveNEOMYCIN SULFATE 0.5GM, COMMERICIAL GRADE, NOT USP

DMF 2621940

CHAS PFIZER AND CO INCInactiveNEOMYCIN SULFATE (VET MED)

DMF 2701940

MERCK AND CO INCInactiveNEOMYCIN SULFATE

DMF 2711940

PENICK CORPInactiveNEOMYCIN SULFATE

DMF 132861998

APOTHEKERNES LABORATORIUM ASInactiveNEOMYCIN SULFATE

DMF 135281998

APOTHEKERNES LABORATORIUM ASInactiveNEOMYCIN SULFATE

DMF 136091998

ROUSSELL UCLAFInactiveNEOMYCIN SULFATE

DMF 136151998

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

Products (1)

#001 — EQ 87.5MG BASE/5ML

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.