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FDA Approval

CARBOPROST TROMETHAMINE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
June 20, 2023
Labeling Type
Human Prescription Drug Label
Carboprost tromethamine(250 ug in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Alembic Pharmaceuticals Limited (F3)

Alembic Pharmaceuticals Inc.

675480734

Products1

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

CARBOPROST TROMETHAMINE

Product Details

NDC Product Code
62332-777
Application Number
ANDA217198
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR
Effective Date
April 22, 2022
Code: U4526F86FJClass: ACTIMQuantity: 250 ug in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 9.45 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACTQuantity: 83 ug in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
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