Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
ANI Pharmaceuticals, Inc.
145588013
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Terbutaline Sulfate
Product Details
NDC Product Code
62559-721Application Number
NDA017849Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
October 16, 2018TerbutalineActive
Code: 576PU70Y8EClass: ACTIBQuantity: 2.5 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
Terbutaline Sulfate
Product Details
NDC Product Code
62559-722Application Number
NDA017849Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
October 16, 2018LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TerbutalineActive
Code: 576PU70Y8EClass: ACTIBQuantity: 5 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT