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BRIELLYN

BRIELLYN (Norethindrone and Ethinyl Estradiol Tablets, USP)

Approved
Approval ID

c0e2c5b4-70ac-4b41-aa71-00e506dbb72f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 23, 2022

Manufacturers
FDA

Glenmark Pharmaceuticals Inc., USA

DUNS: 130597813

Products 1

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

Norethindrone and Ethinyl Estradiol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68462-316
Application NumberANDA090538
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone and Ethinyl Estradiol
Product Specifications
Effective DateMay 23, 2022
FDA Product Classification

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BRIELLYN - FDA Drug Approval Details