Details for New Drug Application (NDA): 213382
NDA 213382 describes GLATIRAMER ACETATE, which is a drug marketed by Chemi Spa, Hybio, Mylan, Scinopharm Taiwan, and Synthon Bv, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the GLATIRAMER ACETATE profile page.
The generic ingredient in GLATIRAMER ACETATE is glatiramer acetate. There is one drug master file entry for this compound. Nine 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 is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the glatiramer acetate profile page.
Summary for 213382
| Tradename: | GLATIRAMER ACETATE |
| Applicant: | Hybio |
| Ingredient: | glatiramer acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 213382
Suppliers and Packaging for NDA: 213382
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLATIRAMER ACETATE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 213382 | ANDA | AJENAT PHARMACEUTICALS LLC | 82983-429 | 82983-429-30 | 30 BLISTER PACK in 1 CARTON (82983-429-30) / 1 SYRINGE in 1 BLISTER PACK (82983-429-01) / 1 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 20MG/ML | ||||
| Approval Date: | Feb 11, 2026 | TE: | AP | RLD: | No | ||||
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