Last Updated: May 10, 2026

Details for New Drug Application (NDA): 217657

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NDA 217657 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 twenty 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-one suppliers are listed for this compound. Additional details are available on the carboprost tromethamine profile page.

Summary for 217657

Tradename:	CARBOPROST TROMETHAMINE
Applicant:	Gland
Ingredient:	carboprost tromethamine
Patents:	0

Pharmacology for NDA: 217657

Medical Subject Heading (MeSH) Categories for 217657

Abortifacient Agents, Nonsteroidal
Oxytocics

Suppliers and Packaging for NDA: 217657

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBOPROST TROMETHAMINE	carboprost tromethamine	INJECTABLE;INJECTION	217657	ANDA	Hospira, Inc.	0409-0064	0409-0064-10	10 VIAL in 1 CARTON (0409-0064-10) / 1 mL in 1 VIAL
CARBOPROST TROMETHAMINE	carboprost tromethamine	INJECTABLE;INJECTION	217657	ANDA	Gland Pharma Limited	68083-584	68083-584-10	10 VIAL in 1 CARTON (68083-584-10) / 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:	Aug 7, 2023	TE:	AP	RLD:	No

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