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SIMLIYA

SIMLIYA (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) 0.15 mg/0.02 mg and 0.01 mg Rx only

Approved
Approval ID

4161f614-6e55-4114-87f7-19bb77f6b09b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 17, 2023

Manufacturers
FDA

Aurobindo Pharma Limited

DUNS: 650082092

Products 1

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

Desogestrel and Ethinyl Estradiol and Ethinyl Estradiol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65862-886
Application NumberANDA206853
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desogestrel and Ethinyl Estradiol and Ethinyl Estradiol
Product Specifications
Effective DateMay 17, 2023
FDA Product Classification

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SIMLIYA - FDA Drug Approval Details