Sumatriptan and Naproxen Sodium
These highlights do not include all the information needed to use SUMATRIPTAN AND NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for SUMATRIPTAN AND NAPROXEN SODIUM TABLETS. SUMATRIPTAN and NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 2008
Approved
Approval ID
6c0c9268-315d-4c0a-943f-58b21b738d11
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2020
Manufacturers
FDA
Innovida Phamaceutique Corporation
DUNS: 080892908
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sumatriptan and Naproxen Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71800-901
Application NumberANDA202803
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sumatriptan and Naproxen Sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2020
FDA Product Classification
INGREDIENTS (17)
NAPROXEN SODIUMActive
Quantity: 500 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUMATRIPTAN SUCCINATEActive
Quantity: 85 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT