MedPath

Vyfemla

Vyfemla™(norethindrone and ethinyl estradiol tablets USP)0.4 mg/0.035 mg

Approved
Approval ID

fa951d03-e464-401d-a4b2-6409bccebe75

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 12, 2016

Manufacturers
FDA

LUPIN LIMITED

DUNS: 675923163

Products 1

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

norethindrone and ethinyl estradiol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57297-875
Application NumberANDA201886
Product Classification
M
Marketing Category
C73584
G
Generic Name
norethindrone and ethinyl estradiol
Product Specifications
Effective DateMay 12, 2016
FDA Product Classification

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Vyfemla - FDA Drug Approval Details