OSCIMIN
OSCIMIN Sublingual Tablets
Approved
Approval ID
2d5fa637-0696-40fe-9bc1-fcb6f07a50f6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2023
Manufacturers
FDA
Larken Laboratories, Inc.
DUNS: 149484540
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
NDC Product Code68047-253
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationSUBLINGUAL
Effective DateOctober 11, 2023
Generic NameHyoscyamine Sulfate
INGREDIENTS (8)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYOSCYAMINE SULFATEActive
Quantity: 0.125 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB