Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
ACS Dobfar SPA
429243025
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
ACS Dobfar SpA
Fresenius Kabi USA, LLC
ACS Dobfar SPA
440886261
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ceftriaxone
Product Details
NDC Product Code
63323-347Application Number
ANDA065329Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
September 30, 2023CeftriaxoneActive
Code: 023Z5BR09KClass: ACTIMQuantity: 2 g in 1 1
Ceftriaxone
Product Details
NDC Product Code
63323-345Application Number
ANDA065329Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
September 30, 2023CeftriaxoneActive
Code: 023Z5BR09KClass: ACTIMQuantity: 500 mg in 1 1
Ceftriaxone
Product Details
NDC Product Code
63323-346Application Number
ANDA065329Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
September 30, 2023CeftriaxoneActive
Code: 023Z5BR09KClass: ACTIMQuantity: 1 g in 1 1