SULINDAC
Sulindac Tablets USP, 200 mg Rx only
Approved
Approval ID
d94e8865-d151-4fb1-bacd-f4e43819e3c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 1, 2022
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SULINDAC
PRODUCT DETAILS
NDC Product Code71205-648
Application NumberANDA072711
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 1, 2022
Generic NameSULINDAC
INGREDIENTS (5)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SULINDACActive
Quantity: 200 mg in 1 1
Code: 184SNS8VUH
Classification: ACTIB