Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Amneal Pharmaceuticals Private Limited Oral Solid Dosage Unit
Amneal Pharmaceuticals of New York LLC
650762060
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
0115-2622Application Number
ANDA075877Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 25, 2020TerbutalineActive
Code: 576PU70Y8EClass: ACTIBQuantity: 5 mg in 1 1
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TERBUTALINE SULFATE
Product Details
NDC Product Code
0115-2611Application Number
ANDA075877Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 25, 2020ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
TerbutalineActive
Code: 576PU70Y8EClass: ACTIBQuantity: 2.5 mg in 1 1
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT