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Generated: November 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206921

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NDA 206921 describes GLATOPA, which is a drug marketed by Sandoz Inc and is included in two NDAs. 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 five 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 206921
Applicant:Sandoz Inc
Ingredient:glatiramer acetate
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 206921
Suppliers and Packaging for NDA: 206921
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLATOPA glatiramer acetate INJECTABLE;SUBCUTANEOUS 206921 ANDA Sandoz Inc 0781-3250 0781-3250-89 12 BLISTER PACK in 1 CARTON (0781-3250-89) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS (0781-3250-71)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength40MG/ML
Approval Date:Feb 12, 2018TE:APRLD:No

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