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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
Fish and Richardson

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 073311

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NDA 073311 describes TOLMETIN SODIUM, which is a drug marketed by Actavis Elizabeth, Ivax Sub Teva Pharms, Mylan, Sandoz, Sun Pharm Industries, Teva, and G And W Labs Inc, and is included in fourteen NDAs. It is available from three suppliers. Additional details are available on the TOLMETIN SODIUM profile page.

The generic ingredient in TOLMETIN SODIUM is tolmetin sodium. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tolmetin sodium profile page.
Summary for 073311
Applicant:Sun Pharm Industries
Ingredient:tolmetin sodium
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 073311
Medical Subject Heading (MeSH) Categories for 073311
Suppliers and Packaging for NDA: 073311
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOLMETIN SODIUM tolmetin sodium CAPSULE;ORAL 073311 ANDA Mutual Pharmaceutical Company, Inc. 53489-506 53489-506-03 250 TABLET in 1 BOTTLE, PLASTIC (53489-506-03)
TOLMETIN SODIUM tolmetin sodium CAPSULE;ORAL 073311 ANDA Mutual Pharmaceutical Company, Inc. 53489-506 53489-506-90 90 TABLET in 1 BOTTLE, PLASTIC (53489-506-90)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 400MG BASE
Approval Date:Nov 27, 1991TE:RLD:No

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Serving leading biopharmaceutical companies globally:

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