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OXYTOCIN 5 USP UNITS IN DEXTROSE 5%

NDA

OXYTOCIN | N019185 | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV

4 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 Chain6 active DMFs6 inactive

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

ASPEN OSS BVOXYTOCIN

DMF 102941993

HEMMO PHARMACEUTICALS PVT LTDOXYTOCIN

DMF 265172012

HYBIO PHARMACEUTICAL CO LTDOXYTOCIN NON STERILE BULK DRUG SUBSTANCE

DMF 349162020

SHENZHEN JYMED TECHNOLOGY CO LTDOXYTOCIN

DMF 354322020

PIRAMAL PHARMA LTDOXYTOCIN USP

DMF 376892023

HARBIN JIXIANGLONG BIOTECH CO LTDOXYTOCIN

DMF 399522024

DIOSYNTH BVInactiveOXYTOCIN ACETATE

DMF 38151980

FERRING ABInactiveOXYTOCIN

DMF 38761980

BIOCHEMIC GESELLSCHAFT MBHInactiveOXYTOCIN SOLUTION 200 I.U./ML

DMF 41911981

MEDIMPEX NORTH AMERICA INCInactiveOXYTOCIN

DMF 45511982

BIOCHEMIC GESELLSCHAFT MBHInactiveOXYTOCIN ACETATE LYOPHILIZED

DMF 78881989

CARLBIOTECH LTD ASInactiveOXYTOCIN

DMF 96041992

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

Products (4)

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#003 — 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Mar 29, 1985

#004 — 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Mar 29, 1985

#002 — 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Mar 29, 1985

#001 — 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Mar 29, 1985

No patent or exclusivity listings for this strength.