Details for New Drug Application (NDA): 090218
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NDA 090218 describes GLATOPA, which is a drug marketed by Sandoz and is included in two NDAs. It is available from two suppliers. 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. Four suppliers are listed for this compound. Additional details are available on the glatiramer acetate profile page.
The generic ingredient in GLATOPA 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 090218
| Tradename: | GLATOPA |
| Applicant: | Sandoz |
| Ingredient: | glatiramer acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 090218
Suppliers and Packaging for NDA: 090218
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLATOPA | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 090218 | ANDA | Sandoz Inc | 0781-3234 | 0781-3234-34 | 30 BLISTER PACK in 1 CARTON (0781-3234-34) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (0781-3234-71) |
| GLATOPA | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 090218 | ANDA | Bryant Ranch Prepack | 63629-8815 | 63629-8815-1 | 30 BLISTER PACK in 1 CARTON (63629-8815-1) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 20MG/ML | ||||
| Approval Date: | Apr 16, 2015 | TE: | AP | RLD: | No | ||||
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