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Tri-Lo- Estarylla

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

Approved
Approval ID

8381db98-f9b2-e894-c07e-5d49f10e4eea

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 21, 2023

Manufacturers
FDA

Xiromed, LLC.

DUNS: 080228637

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 Code70700-120
Application NumberANDA091232
Product Classification
M
Marketing Category
C73584
G
Generic Name
norgestimate and ethinyl estradiol
Product Specifications
Effective DateDecember 21, 2023
FDA Product Classification

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Tri-Lo- Estarylla - FDA Drug Approval Details