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Carboprost Tromethamine

Carboprost Tromethamine Injection, USP

Approved
Approval ID

8a1284cf-002f-4887-a3c0-d73d04b2b869

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 1, 2023

Manufacturers
FDA

Xellia Pharmaceuticals USA LLC

DUNS: 116768762

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

carboprost tromethamine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70594-112
Application NumberANDA216897
Product Classification
M
Marketing Category
C73584
G
Generic Name
carboprost tromethamine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateNovember 1, 2023
FDA Product Classification

INGREDIENTS (1)

CARBOPROST TROMETHAMINEActive
Quantity: 250 ug in 1 mL
Code: U4526F86FJ
Classification: ACTIM

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Carboprost Tromethamine - FDA Drug Approval Details