RyVent
Approved
Approval ID
13ed76c7-49bd-4527-83dc-b4c7d0da9fff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Carwin Pharmaceutical Associates, LLC
DUNS: 079217215
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
carbinoxamine maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15370-130
Application NumberANDA207484
Product Classification
M
Marketing Category
C73584
G
Generic Name
carbinoxamine maleate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CARBINOXAMINE MALEATEActive
Quantity: 6 mg in 1 1
Code: 02O55696WH
Classification: ACTIB