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Last Updated: January 29, 2026

Details for New Drug Application (NDA): 216897

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NDA 216897 describes CARBOPROST TROMETHAMINE, which is a drug marketed by Alembic, Amneal, Ani Pharms, Caplin, Dr Reddys, Eugia Pharma, Gland, Long Grove Pharms, Micro Labs, Onesource Specialty, Sola Pharms, and Sunny, and is included in twelve NDAs. It is available from nineteen suppliers. Additional details are available on the CARBOPROST TROMETHAMINE profile page.

The generic ingredient in CARBOPROST TROMETHAMINE is carboprost tromethamine. There is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the carboprost tromethamine profile page.

Summary for 216897

Tradename:	CARBOPROST TROMETHAMINE
Applicant:	Onesource Specialty
Ingredient:	carboprost tromethamine
Patents:	0

Pharmacology for NDA: 216897

Medical Subject Heading (MeSH) Categories for 216897

Abortifacient Agents, Nonsteroidal
Oxytocics

Suppliers and Packaging for NDA: 216897

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBOPROST TROMETHAMINE	carboprost tromethamine	INJECTABLE;INJECTION	216897	ANDA	Xellia Pharmaceuticals USA LLC	70594-112	70594-112-02	10 VIAL in 1 CARTON (70594-112-02) / 1 mL in 1 VIAL (70594-112-01)
CARBOPROST TROMETHAMINE	carboprost tromethamine	INJECTABLE;INJECTION	216897	ANDA	ONESOURCE SPECIALTY PHARMA LIMITED	83270-002	83270-002-10	10 VIAL in 1 CARTON (83270-002-10) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.25MG BASE/ML
Approval Date:	Jul 25, 2023	TE:	AP	RLD:	No

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