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FDA Approval

Aurovela 1/20

CompanyAurobindo Pharma Limited (DUNS: 650082092)

Effective Date

November 21, 2023

Labeling Type

Human Prescription Drug Label

Active Ingredients

Norethisterone(1 mg in 1 1)

Ethinylestradiol(20 ug in 1 1)

Manufacturing Establishments (1)

Aurobindo Pharma Limited

Labeler

Aurobindo Pharma Limited

DUNS Number

650381903

Products (1)

Aurovela 1/20

NDC Product Code

65862-939

Application Number

ANDA207506

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 21, 2023

Ingredients

NorethisteroneActive

Code: 9S44LIC7OJClass: ACTIBQuantity: 1 mg in 1 1

EthinylestradiolActive

Code: 423D2T571UClass: ACTIBQuantity: 20 ug in 1 1

SUCROSEInactive

Code: C151H8M554Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

.ALPHA.-TOCOPHEROLInactive

Code: H4N855PNZ1Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

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