MedPath

Orsythia

ORSYTHIA (LEVONORGESTREL (0.1 mg) AND ETHINYL ESTRADIOL (0.02 mg) TABLETS USP)

Approved
Approval ID

5acb5f67-c6cc-4fd6-8702-92e2974023de

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 22, 2017

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.

levonorgestrel and ethinyl estradiol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-1380
Application NumberANDA077099
Product Classification
M
Marketing Category
C73584
G
Generic Name
levonorgestrel and ethinyl estradiol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 25, 2017
FDA Product Classification

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.