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FDA Approval

Naproxen

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

FDA Approval Summary

Company
Effective Date
June 10, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Naproxen(375 mg in 1 1)

Manufacturing Establishments1

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

A-S Medication Solutions

A-S Medication Solutions

830016429

Products3

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

Naproxen

Product Details

NDC Product Code
50090-0472
Application Number
ANDA075927
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 3, 2021
NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 375 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Naproxen

Product Details

NDC Product Code
50090-0478
Application Number
ANDA075927
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 3, 2021
NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 500 mg in 1 1
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT

Naproxen

Product Details

NDC Product Code
50090-0468
Application Number
ANDA075927
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 3, 2021
NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 250 mg in 1 1
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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