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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 216882


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NDA 216882 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 216882
Tradename:CARBOPROST TROMETHAMINE
Applicant:Caplin
Ingredient:carboprost tromethamine
Patents:0
Pharmacology for NDA: 216882
Medical Subject Heading (MeSH) Categories for 216882
Suppliers and Packaging for NDA: 216882
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBOPROST TROMETHAMINE carboprost tromethamine INJECTABLE;INJECTION 216882 ANDA Caplin Steriles Limited 65145-132 65145-132-10 10 VIAL in 1 CARTON (65145-132-10) / 1 mL in 1 VIAL (65145-132-01)
CARBOPROST TROMETHAMINE carboprost tromethamine INJECTABLE;INJECTION 216882 ANDA Fresenius Kabi USA, LLC 65219-579 65219-579-01 10 VIAL in 1 CARTON (65219-579-01) / 1 mL in 1 VIAL (65219-579-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.25MG BASE/ML
Approval Date:Feb 13, 2023TE:APRLD:No

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