Afirmelle

Aurobindo Pharma Limited🇺🇸 United States

FDA Page

Effective Date: Dec 6, 2021
Approval ID: dd6122cd-b7ba-4fe3-bde5-910882475b67
Products: 1 registered
Version: 8

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

Afirmelle (Levonorgestrel and Ethinyl Estradiol Tablets USP) 0.1 mg/0.02 mg Rx only Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

Quick Stats

Total Products1

Labelers2

Label Sections27

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.