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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
October 19, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Carboprost tromethamine(250 ug in 1 mL)

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
81298-5010
Application Number
ANDA214499
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR
Effective Date
October 19, 2022
Code: U4526F86FJClass: ACTIMQuantity: 250 ug in 1 mL
Hydrochloric AcidInactive
Code: QTT17582CBClass: IACT
Benzyl AlcoholInactive
Code: LKG8494WBHClass: IACT
Sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
Sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
TromethamineInactive
Code: 023C2WHX2VClass: IACT
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