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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 206936


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NDA 206936 describes GLATIRAMER ACETATE, which is a drug marketed by Mylan and Synthon Pharms Inc and is included in four 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. Four suppliers are listed for this compound. Additional details are available on the glatiramer acetate profile page.
Summary for 206936
Tradename:GLATIRAMER ACETATE
Applicant:Mylan
Ingredient:glatiramer acetate
Patents:0
Medical Subject Heading (MeSH) Categories for 206936
Suppliers and Packaging for NDA: 206936
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLATIRAMER ACETATE glatiramer acetate INJECTABLE;SUBCUTANEOUS 206936 ANDA Mylan Pharmaceuticals Inc. 0378-6961 0378-6961-12 12 BLISTER PACK in 1 CARTON (0378-6961-12) / 1 SYRINGE in 1 BLISTER PACK (0378-6961-32) / 1 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength40MG/ML
Approval Date:Oct 3, 2017TE:APRLD:No

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