Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Wockhardt Limited
650069115
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Wockhardt Limited
Wockhardt USA LLC.
Wockhardt Limited
676257570
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FELODIPINE
Product Details
NDC Product Code
64679-412Application Number
ANDA091484Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 26, 2019FelodipineActive
Code: OL961R6O2CClass: ACTIBQuantity: 5 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7FClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8FClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
FELODIPINE
Product Details
NDC Product Code
64679-414Application Number
ANDA091484Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 26, 2019CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7FClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8FClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
FelodipineActive
Code: OL961R6O2CClass: ACTIBQuantity: 10 mg in 1 1
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
FELODIPINE
Product Details
NDC Product Code
64679-411Application Number
ANDA091484Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 26, 2019POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FelodipineActive
Code: OL961R6O2CClass: ACTIBQuantity: 2.5 mg in 1 1
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7FClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8FClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT