Last Updated: May 3, 2026

Details for New Drug Application (NDA): 213118

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NDA 213118 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 213118

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

Pharmacology for NDA: 213118

Medical Subject Heading (MeSH) Categories for 213118

Abortifacient Agents, Nonsteroidal
Oxytocics

Suppliers and Packaging for NDA: 213118

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBOPROST TROMETHAMINE	carboprost tromethamine	INJECTABLE;INJECTION	213118	ANDA	Omnivium Pharmaceuticals LLC	81665-202	81665-202-01	1 mL in 1 AMPULE (81665-202-01)
CARBOPROST TROMETHAMINE	carboprost tromethamine	INJECTABLE;INJECTION	213118	ANDA	Omnivium Pharmaceuticals LLC	81665-202	81665-202-10	10 AMPULE in 1 CARTON (81665-202-10) / 1 mL in 1 AMPULE (81665-202-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.25MG BASE/ML
Approval Date:	Mar 25, 2021	TE:	AP	RLD:	No

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