Glatiramer Acetate is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Glatiramer Acetate.
| Product ID | 0378-6960_0fbb771d-a365-421a-983d-052726ae39a2 |
| NDC | 0378-6960 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Glatiramer Acetate |
| Generic Name | Glatiramer Acetate |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 2017-10-04 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA091646 |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | GLATIRAMER ACETATE |
| Active Ingredient Strength | 20 mg/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2017-10-04 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA091646 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2017-10-04 |
| Marketing Category | ANDA |
| Application Number | ANDA091646 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2017-10-04 |
| Ingredient | Strength |
|---|---|
| GLATIRAMER ACETATE | 20 mg/mL |
| SPL SET ID: | f38b5606-d2d7-44ec-912f-46882aa2fa7b |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0378-6960 | Glatiramer Acetate | glatiramer acetate |
| 0378-6961 | Glatiramer Acetate | Glatiramer |
| 68546-317 | Copaxone | Glatiramer Acetate |
| 68546-325 | Copaxone | Glatiramer Acetate |
| 0781-3234 | Glatopa | Glatiramer Acetate |
| 0781-3250 | Glatopa | Glatiramer Acetate |
| 63629-8815 | Glatopa | Glatiramer Acetate |
| 63629-8816 | Glatopa | Glatiramer Acetate |