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Norlyda

NORLYDA™ (norethindrone tablets, USP) 0.35 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.

Approved
Approval ID

d692cf63-803d-42b5-81fe-536a94b41146

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 13, 2021

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 1

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

norethindrone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-3235
Application NumberANDA202260
Product Classification
M
Marketing Category
C73584
G
Generic Name
norethindrone
Product Specifications
Effective DateMay 17, 2019
FDA Product Classification

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Norlyda - FDA Drug Approval Details