Symax Duotab
Symax Duotab Hyoscyamine Sulfate BIPHASIC TABLETS* Rx Only *U.S. Patent No. 9,308,164
Approved
Approval ID
0cab4421-d99e-4cd0-8993-e46c484dc3cb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 21, 2023
Manufacturers
FDA
Capellon Pharmaceuticals, LLC
DUNS: 124568093
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hyoscyamine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64543-118
Product Classification
G
Generic Name
Hyoscyamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 21, 2023
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CALCIUM PHOSPHATEInactive
Code: 97Z1WI3NDX
Classification: IACT
HYOSCYAMINE SULFATEActive
Quantity: 0.375 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB