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Last Updated: September 24, 2020

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Details for New Drug Application (NDA): 206936

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NDA 206936 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 206936
Ingredient:glatiramer acetate
Formulation / Manufacturing:see details
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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim

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