Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Amneal Pharmaceuticals Private Limited
Amneal Pharmaceuticals LLC
Amneal Pharmaceuticals of New York, LLC
860156658
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
70121-1680Application Number
ANDA215337Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
December 23, 2023Carboprost tromethamineActive
Code: U4526F86FJClass: ACTIMQuantity: 250 ug in 1 mL
TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACTQuantity: 83 ug in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 9.45 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT