Lithostat
LITHOSTAT (Acetohydroxamic Acid) Tablets
Approved
Approval ID
6660b616-a82d-9109-19ce-2bdf9747acea
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.
acetohydroxamic acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0178-0500
Application NumberNDA018749
Product Classification
M
Marketing Category
C73594
G
Generic Name
acetohydroxamic acid
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2024
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Quantity: 240 mg in 1 1
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Quantity: 5 mg in 1 1
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Quantity: 3 mg in 1 1
Code: 70097M6I30
Classification: IACT
PEPPERMINT OILInactive
Quantity: 0.2 mg in 1 1
Code: AV092KU4JH
Classification: IACT
ACETOHYDROXAMIC ACIDActive
Quantity: 250 mg in 1 1
Code: 4RZ82L2GY5
Classification: ACTIB