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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Federal Trade Commission
US Army

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090218

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NDA 090218 describes GLATOPA, which is a drug marketed by Sandoz Inc and is included in one NDA. It is available from one supplier. Additional details are available on the GLATOPA profile page.

The generic ingredient in GLATOPA is glatiramer acetate. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the glatiramer acetate profile page.
Summary for 090218
Applicant:Sandoz Inc
Ingredient:glatiramer acetate
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 090218
Suppliers and Packaging for NDA: 090218
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLATOPA glatiramer acetate INJECTABLE;SUBCUTANEOUS 090218 ANDA Sandoz Inc 0781-3234 0781-3234-34 30 BLISTER PACK in 1 CARTON (0781-3234-34) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS (0781-3234-71)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength20MG/ML
Approval Date:Apr 16, 2015TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Johnson and Johnson

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