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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 080197


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NDA 080197 describes SULFASALAZINE, which is a drug marketed by Nuvo Pharms Inc, Watson Labs, Chartwell, Epic Pharma Llc, Sun Pharm Industries, and Superpharm, and is included in ten NDAs. It is available from six suppliers. Additional details are available on the SULFASALAZINE profile page.

The generic ingredient in SULFASALAZINE is sulfasalazine. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the sulfasalazine profile page.
Summary for 080197
Tradename:SULFASALAZINE
Applicant:Chartwell
Ingredient:sulfasalazine
Patents:0
Pharmacology for NDA: 080197
Suppliers and Packaging for NDA: 080197
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SULFASALAZINE sulfasalazine TABLET;ORAL 080197 ANDA Chartwell RX, LLC. 62135-960 62135-960-01 100 TABLET in 1 BOTTLE (62135-960-01)
SULFASALAZINE sulfasalazine TABLET;ORAL 080197 ANDA Chartwell RX, LLC. 62135-960 62135-960-05 500 TABLET in 1 BOTTLE (62135-960-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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