Details for New Drug Application (NDA): 091646
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NDA 091646 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.
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 091646
| Tradename: | GLATIRAMER ACETATE |
| Applicant: | Mylan |
| Ingredient: | glatiramer acetate |
| Patents: | 0 |
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: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 20MG/ML | ||||
| Approval Date: | Oct 3, 2017 | TE: | AP | RLD: | No | ||||
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