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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 215337

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NDA 215337 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 eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the carboprost tromethamine profile page.

Summary for 215337

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

Pharmacology for NDA: 215337

Medical Subject Heading (MeSH) Categories for 215337

Abortifacient Agents, Nonsteroidal
Oxytocics

Suppliers and Packaging for NDA: 215337

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBOPROST TROMETHAMINE	carboprost tromethamine	INJECTABLE;INJECTION	215337	ANDA	Amneal Pharmaceuticals LLC	70121-1680	70121-1680-7	10 VIAL in 1 CARTON (70121-1680-7) / 1 mL in 1 VIAL (70121-1680-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.25MG BASE/ML
Approval Date:	Jan 27, 2022	TE:	AP	RLD:	No

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