Sulindac
SULINDAC TABLETS, USP
Approved
Approval ID
d126f8a4-bc39-453c-bdd4-764ce4e1760d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 13, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SULINDAC
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0799
Application NumberANDA073262
Product Classification
M
Marketing Category
C73584
G
Generic Name
SULINDAC
Product Specifications
Route of AdministrationORAL
Effective DateApril 13, 2010
FDA Product Classification
INGREDIENTS (6)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SULINDACActive
Quantity: 150 mg in 1 1
Code: 184SNS8VUH
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT