Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glatopa
Product Details
NDC Product Code
0781-3250Application Number
ANDA206921Marketing Category
ANDA (C73584)Route of Administration
SUBCUTANEOUSEffective Date
October 31, 2018GlatiramerActive
Code: 5M691HL4BOClass: ACTIBQuantity: 40 mg in 1 mL
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
Glatopa
Product Details
NDC Product Code
0781-3234Application Number
ANDA090218Marketing Category
ANDA (C73584)Route of Administration
SUBCUTANEOUSEffective Date
October 31, 2018GlatiramerActive
Code: 5M691HL4BOClass: ACTIBQuantity: 20 mg in 1 mL
MANNITOLInactive
Code: 3OWL53L36AClass: IACT