Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Biomes Pharmaceuticals
078644310
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Biomes Pharmaceuticals
Biomes Pharmaceuticals
Biomes Pharmaceuticals
078644310
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
69150-138Application Number
ANDA091416Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 19, 2016MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 250 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONESInactive
Code: FZ989GH94EClass: IACT
NAPROXEN
Product Details
NDC Product Code
69150-139Application Number
ANDA091416Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 19, 2016MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 375 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONESInactive
Code: FZ989GH94EClass: IACT
NAPROXEN
Product Details
NDC Product Code
69150-140Application Number
ANDA091416Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 19, 2016NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 500 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONESInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT