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Tri-VyLibra Lo

These highlights do not include all the information needed to use TRI-VYLIBRA LO safely and effectively. See full prescribing information for TRI-VYLIBRA LO. Tri-VyLibra Lo (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 1989

Approved
Approval ID

bd51a08e-cd45-4315-9bca-41794450ef16

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 4, 2023

Manufacturers
FDA

Afaxys Pharma, LLC

DUNS: 080508656

Products 1

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

Norgestimate and Ethinyl Estradiol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50102-231
Application NumberANDA205762
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norgestimate and Ethinyl Estradiol
Product Specifications
Effective DateMay 4, 2023
FDA Product Classification

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Tri-VyLibra Lo - FDA Drug Approval Details