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Sulfasalazine

Sulfasalazine Tablets, USP Rx only

Approved
Approval ID

9d6cf030-aaed-4427-bceb-b6a04af70bee

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 4, 2024

Manufacturers
FDA

REMEDYREPACK INC.

DUNS: 829572556

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sulfasalazine

PRODUCT DETAILS

NDC Product Code70518-0185
Application NumberANDA085828
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 4, 2024
Generic NameSulfasalazine

INGREDIENTS (5)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SULFASALAZINEActive
Quantity: 500 mg in 1 1
Code: 3XC8GUZ6CB
Classification: ACTIB

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Sulfasalazine - FDA Drug Approval Details