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FDA Approval

LIPITOR

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
PHARMAKON, LLC
DUNS: 964749860
Effective Date
December 2, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Atorvastatin(10 mg in 1 1)

Products4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

LIPITOR

Product Details

NDC Product Code
49299-1090
Application Number
NDA020702
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
December 3, 2010
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
Code: 48A5M73Z4QClass: ACTIBQuantity: 10 mg in 1 1
calcium carbonateInactive
Code: H0G9379FGKClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
candelilla waxInactive
Code: WL0328HX19Class: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671PClass: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1AClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT

LIPITOR

Product Details

NDC Product Code
49299-1092
Application Number
NDA020702
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
December 3, 2010
magnesium stearateInactive
Code: 70097M6I30Class: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1AClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
Code: 48A5M73Z4QClass: ACTIBQuantity: 40 mg in 1 1
calcium carbonateInactive
Code: H0G9379FGKClass: IACT
candelilla waxInactive
Code: WL0328HX19Class: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671PClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT

LIPITOR

Product Details

NDC Product Code
49299-1091
Application Number
NDA020702
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
December 3, 2010
candelilla waxInactive
Code: WL0328HX19Class: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1AClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671PClass: IACT
Code: 48A5M73Z4QClass: ACTIBQuantity: 20 mg in 1 1
calcium carbonateInactive
Code: H0G9379FGKClass: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT

LIPITOR

Product Details

NDC Product Code
49299-1093
Application Number
NDA020702
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
December 3, 2010
Code: 48A5M73Z4QClass: ACTIBQuantity: 80 mg in 1 1
calcium carbonateInactive
Code: H0G9379FGKClass: IACT
candelilla waxInactive
Code: WL0328HX19Class: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671PClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1AClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
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