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FDA Approval

Naproxen Sodium

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

FDA Approval Summary

Company
Effective Date
June 30, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Naproxen(500 mg in 1 1)

Products3

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

Naproxen sodium

Product Details

NDC Product Code
0480-0952
Application Number
ANDA075416
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 30, 2022
NaproxenActive
Code: 9TN87S3A3CClass: ACTIMQuantity: 500 mg in 1 1

Naproxen Sodium

Product Details

NDC Product Code
0480-0951
Application Number
ANDA075416
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 30, 2022
NaproxenActive
Code: 9TN87S3A3CClass: ACTIMQuantity: 375 mg in 1 1

Naproxen Sodium

Product Details

NDC Product Code
0480-0953
Application Number
ANDA075416
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 30, 2022
NaproxenActive
Code: 9TN87S3A3CClass: ACTIMQuantity: 750 mg in 1 1
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