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FDA Approval

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

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

FDA Approval Summary

Company
Effective Date
January 15, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ethinylestradiol(0.02 mg in 1 1)
Norethisterone(1 mg in 1 1)

Products1

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

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Product Details

NDC Product Code
0378-7280
Application Number
ANDA202771
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 6, 2017
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
Code: 423D2T571UClass: ACTIBQuantity: 0.02 mg in 1 1
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01Class: IACT
Code: 9S44LIC7OJClass: ACTIBQuantity: 1 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K25Inactive
Code: K0KQV10C35Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
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