Almotriptan Malate
These highlights do not include all the information needed to use ALMOTRIPTAN TABLETS safely and effectively. See full prescribing information for ALMOTRIPTAN TABLETS. ALMOTRIPTAN tablets, for oral useInitial U.S. Approval: 2001
Approved
Approval ID
35617039-9f33-401b-bac3-8f85c65fa2c7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 9, 2017
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Almotriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-5246
Application NumberANDA205171
Product Classification
M
Marketing Category
C73584
G
Generic Name
Almotriptan
Product Specifications
Route of AdministrationORAL
Effective DateMay 9, 2017
FDA Product Classification
INGREDIENTS (9)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
ALMOTRIPTAN MALATEActive
Quantity: 12.5 mg in 1 1
Code: PJP312605E
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Almotriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-5245
Application NumberANDA205171
Product Classification
M
Marketing Category
C73584
G
Generic Name
Almotriptan
Product Specifications
Route of AdministrationORAL
Effective DateMay 9, 2017
FDA Product Classification
INGREDIENTS (9)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ALMOTRIPTAN MALATEActive
Quantity: 6.25 mg in 1 1
Code: PJP312605E
Classification: ACTIM
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT