NDC 0781-3250
Glatopa
Glatiramer Acetate
Glatopa is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Glatiramer Acetate.
| Product ID | 0781-3250_027279ad-06a6-4ccf-9c8a-c506fb3f1226 |
| NDC | 0781-3250 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Glatopa |
| Generic Name | Glatiramer Acetate |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 2018-02-12 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA206921 |
| Labeler Name | Sandoz Inc |
| Substance Name | GLATIRAMER ACETATE |
| Active Ingredient Strength | 40 mg/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 0781-3250-89
12 BLISTER PACK in 1 CARTON (0781-3250-89) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS (0781-3250-71)
| Marketing Start Date | 2018-02-12 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0781-3250-89 [00781325089]
Glatopa INJECTION, SOLUTION
| Marketing Category | ANDA |
| Application Number | ANDA206921 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2018-02-12 |
NDC 0781-3250-71 [00781325071]
Glatopa INJECTION, SOLUTION
| Marketing Category | ANDA |
| Application Number | ANDA206921 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2018-02-12 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| GLATIRAMER ACETATE | 40 mg/mL |
OpenFDA Data
| SPL SET ID: | 5f01e40a-b6f6-40fb-b37c-3d06f1428e86 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "Glatopa" or generic name "Glatiramer Acetate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0781-3234 | Glatopa | Glatiramer Acetate |
| 0781-3250 | Glatopa | Glatiramer Acetate |
| 63629-8815 | Glatopa | Glatiramer Acetate |
| 63629-8816 | Glatopa | Glatiramer Acetate |
| 68546-317 | Copaxone | Glatiramer Acetate |
| 68546-325 | Copaxone | Glatiramer Acetate |
| 0378-6960 | Glatiramer Acetate | glatiramer acetate |
Trademark Results [Glatopa]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GLATOPA 86390315 4819540 Live/Registered |
Novartis AG 2014-09-10 |
 GLATOPA 85271930 not registered Dead/Abandoned |
Novartis AG 2011-03-21 |
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