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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 217198


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NDA 217198 describes CARBOPROST TROMETHAMINE, which is a drug marketed by Alembic, Amneal, Ani Pharms, Caplin, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Long Grove Pharms, Micro Labs, Sola Pharms, Steriscience Speclts, and Sunny, and is included in twelve NDAs. It is available from seventeen 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. Eighteen suppliers are listed for this compound. Additional details are available on the carboprost tromethamine profile page.
Summary for 217198
Tradename:CARBOPROST TROMETHAMINE
Applicant:Alembic
Ingredient:carboprost tromethamine
Patents:0
Pharmacology for NDA: 217198
Medical Subject Heading (MeSH) Categories for 217198
Suppliers and Packaging for NDA: 217198
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBOPROST TROMETHAMINE carboprost tromethamine INJECTABLE;INJECTION 217198 ANDA Alembic Pharmaceuticals Limited 46708-777 46708-777-10 10 VIAL in 1 CARTON (46708-777-10) / 1 mL in 1 VIAL (46708-777-01)
CARBOPROST TROMETHAMINE carboprost tromethamine INJECTABLE;INJECTION 217198 ANDA Alembic Pharmaceuticals Inc. 62332-777 62332-777-10 10 VIAL in 1 CARTON (62332-777-10) / 1 mL in 1 VIAL (62332-777-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.25MG BASE/ML
Approval Date:Jun 15, 2023TE:APRLD:No

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