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FDA Approval

Ibuprofen

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

FDA Approval Summary

Company
Effective Date
April 28, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ibuprofen(600 mg in 1 1)

Manufacturing Establishments1

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

Altura Pharmaceuticals, Inc.

Altura Pharmaceuticals, Inc.

006890545

Products3

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

Ibuprofen

Product Details

NDC Product Code
63874-324
Application Number
ANDA078558
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 28, 2010
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 600 mg in 1 1

Ibuprofen

Product Details

NDC Product Code
63874-322
Application Number
ANDA078558
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 28, 2010
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 400 mg in 1 1

Ibuprofen

Product Details

NDC Product Code
63874-323
Application Number
ANDA078558
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 28, 2010
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 800 mg in 1 1
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