Last Updated: August 2, 2026

Details for New Drug Application (NDA): 219529

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NDA 219529 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, Somerset Theraps Llc, and Sunny, and is included in thirteen NDAs. It is available from twenty-one 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-two suppliers are listed for this compound. Additional details are available on the carboprost tromethamine profile page.

Summary for 219529

Tradename:	CARBOPROST TROMETHAMINE
Applicant:	Somerset Theraps Llc
Ingredient:	carboprost tromethamine
Patents:	0

Pharmacology for NDA: 219529

Medical Subject Heading (MeSH) Categories for 219529

Abortifacient Agents, Nonsteroidal
Oxytocics

Suppliers and Packaging for NDA: 219529

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBOPROST TROMETHAMINE	carboprost tromethamine	INJECTABLE;INJECTION	219529	ANDA	Somerset Therapeutics, LLC	70069-825	70069-825-10	10 SYRINGE in 1 CARTON (70069-825-10) / 1 mL in 1 SYRINGE (70069-825-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.25MG BASE/ML
Approval Date:	May 27, 2026	TE:	AP	RLD:	No

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