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Generated: August 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091646

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NDA 091646 describes GLATIRAMER ACETATE, which is a drug marketed by Mylan and is included in two NDAs. It is available from one supplier. Additional details are available on the GLATIRAMER ACETATE profile page.

The generic ingredient in GLATIRAMER ACETATE 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 091646
Tradename:GLATIRAMER ACETATE
Applicant:Mylan
Ingredient:glatiramer acetate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 091646
Suppliers and Packaging for NDA: 091646
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLATIRAMER ACETATE glatiramer acetate INJECTABLE;SUBCUTANEOUS 091646 ANDA Mylan Pharmaceuticals Inc. 0378-6960 0378-6960-93 30 BLISTER PACK in 1 CARTON (0378-6960-93) > 1 SYRINGE in 1 BLISTER PACK (0378-6960-32) > 1 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength20MG/ML
Approval Date:Oct 3, 2017TE:APRLD:No

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