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 | 0781-3234_027279ad-06a6-4ccf-9c8a-c506fb3f1226 |
NDC | 0781-3234 |
Product Type | Human Prescription Drug |
Proprietary Name | Glatopa |
Generic Name | Glatiramer Acetate |
Dosage Form | Injection, Solution |
Route of Administration | SUBCUTANEOUS |
Marketing Start Date | 2015-06-18 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA090218 |
Labeler Name | Sandoz Inc |
Substance Name | GLATIRAMER ACETATE |
Active Ingredient Strength | 20 mg/mL |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2015-06-18 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA090218 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2015-06-18 |
Marketing Category | ANDA |
Application Number | ANDA090218 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2015-06-18 |
Ingredient | Strength |
---|---|
GLATIRAMER ACETATE | 20 mg/mL |
SPL SET ID: | 5f01e40a-b6f6-40fb-b37c-3d06f1428e86 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
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 |
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 |