Details for New Drug Application (NDA): 208468
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NDA 208468 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 two 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the glatiramer acetate profile page.
Summary for 208468
| Tradename: | GLATIRAMER ACETATE |
| Applicant: | Chemi Spa |
| Ingredient: | glatiramer acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 208468
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 20MG/ML | ||||
| Approval Date: | May 7, 2025 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 40MG/ML | ||||
| Approval Date: | May 7, 2025 | TE: | AP | RLD: | No | ||||
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