Details for New Drug Application (NDA): 203857
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NDA 203857 describes GLATIRAMER ACETATE, which is a drug marketed by Chemi Spa, Mylan, and Synthon Pharms Inc, and is included in five NDAs. It is available from four suppliers. 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. Seven 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. Seven suppliers are listed for this compound. Additional details are available on the glatiramer acetate profile page.
Summary for 203857
| Tradename: | GLATIRAMER ACETATE |
| Applicant: | Synthon Pharms Inc |
| Ingredient: | glatiramer acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 203857
Suppliers and Packaging for NDA: 203857
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLATIRAMER ACETATE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 203857 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-990 | 47335-990-02 | 30 BLISTER PACK in 1 CARTON (47335-990-02) / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 20MG/ML | ||||
| Approval Date: | Sep 25, 2024 | TE: | AP | RLD: | No | ||||
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