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FDA Approval

WYMZYA FE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
December 19, 2012
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Warner Chilcott Company, LLC

Lupin Pharmaceuticals, Inc.

152356536

Products1

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

WYMZYA FE

Product Details

NDC Product Code
68180-898
Application Number
NDA021490
Marketing Category
NDA authorized generic (C73605)
Effective Date
December 16, 2009
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