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FDA Approval

Incassia

CompanyAurobindo Pharma Limited (DUNS: 650082092)

Effective Date

September 14, 2021

Labeling Type

Human Prescription Drug Label

Active Ingredients

Norethisterone(0.35 mg in 1 1)

Manufacturing Establishments (1)

Aurobindo Pharma Limited

Labeler

Aurobindo Pharma Limited

DUNS Number

650381903

Products (1)

Incassia

NDC Product Code

65862-925

Application Number

ANDA207304

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 14, 2021

Ingredients

NorethisteroneActive

Code: T18F433X4SClass: ACTIBQuantity: 0.35 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

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