Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
State of Florida DOH Central Pharmacy
State of Florida DOH Central Pharmacy
829348114
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LAMIVUDINE
Product Details
NDC Product Code
53808-0844Application Number
ANDA091606Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 12, 2013LamivudineActive
Code: 2T8Q726O95Class: ACTIBQuantity: 300 mg in 1 1
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
LAMIVUDINE
Product Details
NDC Product Code
53808-0843Application Number
ANDA091606Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 12, 2013LamivudineActive
Code: 2T8Q726O95Class: ACTIBQuantity: 150 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT