Thiola
THIOLA (Tiopronin) Tablets
Approved
Approval ID
494a714e-923c-cd57-df6c-12886afb265a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2024
Manufacturers
FDA
Mission Pharmacal Company
DUNS: 008117095
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tiopronin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0178-0900
Application NumberNDA019569
Product Classification
M
Marketing Category
C73594
G
Generic Name
tiopronin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2024
FDA Product Classification
INGREDIENTS (14)
LACTOSEInactive
Quantity: 39 mg in 1 1
Code: J2B2A4N98G
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
SUCROSEInactive
Quantity: 123 mg in 1 1
Code: C151H8M554
Classification: IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Quantity: 28.8 mg in 1 1
Code: 905HNO1SIH
Classification: IACT
CARNAUBA WAXInactive
Quantity: 0.05 mg in 1 1
Code: R12CBM0EIZ
Classification: IACT
CALCIUM CARBONATEInactive
Quantity: 42.7 mg in 1 1
Code: H0G9379FGK
Classification: IACT
ETHYLCELLULOSESInactive
Quantity: 20 mg in 1 1
Code: 7Z8S9VYZ4B
Classification: IACT
MAGNESIUM SILICATEInactive
Quantity: 14.4 mg in 1 1
Code: 9B9691B2N9
Classification: IACT
MAGNESIUM STEARATEInactive
Quantity: 5.4 mg in 1 1
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Quantity: 1.7 mg in 1 1
Code: 15FIX9V2JP
Classification: IACT
TIOPRONINActive
Quantity: 100 mg in 1 1
Code: C5W04GO61S
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HYDROXYPROPYL CELLULOSE (70000 WAMW)Inactive
Code: 66O7AQV0RT
Classification: IACT