Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Prinston Pharmaceutical Inc.
967289799
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zhejiang Huahai Pharmaceutical Co., LTD
Solco Healthcare US, LLC
Prinston Pharmaceutical Inc.
530732460
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NEBIVOLOL
Product Details
NDC Product Code
43547-526Application Number
ANDA212682Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 14, 2022CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6KClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
NebivololActive
Code: 030Y90569UClass: ACTIBQuantity: 10 mg in 1 1
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFOACETATEInactive
Code: D0Y70F2B9JClass: IACT
NEBIVOLOL
Product Details
NDC Product Code
43547-525Application Number
ANDA212682Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 14, 2022CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SODIUM LAURYL SULFOACETATEInactive
Code: D0Y70F2B9JClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
NebivololActive
Code: 030Y90569UClass: ACTIBQuantity: 5 mg in 1 1
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
NEBIVOLOL
Product Details
NDC Product Code
43547-524Application Number
ANDA212682Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 14, 2022POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SODIUM LAURYL SULFOACETATEInactive
Code: D0Y70F2B9JClass: IACT
NebivololActive
Code: 030Y90569UClass: ACTIBQuantity: 2.5 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
NEBIVOLOL
Product Details
NDC Product Code
43547-527Application Number
ANDA212682Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 14, 2022LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
NebivololActive
Code: 030Y90569UClass: ACTIBQuantity: 20 mg in 1 1
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT