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Application 206921
- Type
- ANDA
- Sponsor
- SANDOZ INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GLATOPA | GLATIRAMER ACETATE | INJECTABLE;SUBCUTANEOUS | 40MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0781-3250 | Glatopa | Glatiramer Acetate | Sandoz Inc | ANDA | Current |
| 0781-3250 | Glatopa | Glatiramer Acetate | Sandoz Inc | ANDA | Current |
| 0781-3250 | Glatopa | Glatiramer Acetate | Sandoz Inc | ANDA | Current |
| 0781-3250 | Glatopa | Glatiramer Acetate | Sandoz Inc | ANDA | Current |
| 0781-3250 | Glatopa | Glatiramer Acetate | Sandoz Inc | ANDA | Current |
| 0781-3250 | Glatopa | Glatiramer Acetate | Sandoz Inc | ANDA | Current |
| 63629-8816 | Glatopa | Glatiramer Acetate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8816 | Glatopa | Glatiramer Acetate | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 52640 | ORIG | 2018-02-14 |