Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Steriscience Pte. Limited
659844097
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Stelis Biopharma Limited
Xellia Pharmaceuticals USA LLC
Steriscience Pte. Limited
867530307
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
70594-112Application Number
ANDA216897Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
November 1, 2023Carboprost tromethamineActive
Code: U4526F86FJClass: ACTIMQuantity: 250 ug in 1 mL