Norethindrone Acetate and Ethinyl Estradiol

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Novast Laboratories, Ltd.

DUNS Number

527695995

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Novast Laboratories, Ltd.

Labeler

Nivagen Pharmaceuticals, Inc.

Registrant

Novast Laboratories, Ltd.

DUNS Number

527695995

Products2

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

Product Details

NDC Product Code

75834-129

Application Number

ANDA203435

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 22, 2022

Ingredients

NorethisteroneActive

Code: 9S44LIC7OJClass: ACTIBQuantity: 0.5 mg in 1 1

EthinylestradiolActive

Code: 423D2T571UClass: ACTIBQuantity: 0.0025 mg in 1 1

Lactose monohydrateInactive

Code: EWQ57Q8I5XClass: IACT

POLYETHYLENE GLYCOL 300Inactive

Code: 5655G9Y8AQClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive

Code: 8136Y38GY5Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

.ALPHA.-TOCOPHEROLInactive

Code: H4N855PNZ1Class: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

TalcInactive

Code: 7SEV7J4R1UClass: IACT

Polyvinyl Alcohol, UnspecifiedInactive

Code: 532B59J990Class: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62Class: IACT