Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090218
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GLATOPA | GLATIRAMER ACETATE | 20MG/ML | INJECTABLE;SUBCUTANEOUS | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/16/2015 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/090218Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090218Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/090218Orig1s000.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/090218Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/19/2024 | SUPPL-28 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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05/08/2023 | SUPPL-27 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
09/21/2022 | SUPPL-25 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
09/21/2022 | SUPPL-24 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
11/09/2020 | SUPPL-21 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
11/09/2020 | SUPPL-20 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
11/09/2020 | SUPPL-17 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
11/09/2020 | SUPPL-8 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
11/09/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
11/09/2020 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/16/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/090218Orig1s000lbl.pdf |
GLATOPA
INJECTABLE;SUBCUTANEOUS; 20MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
COPAXONE | GLATIRAMER ACETATE | 20MG/ML | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 020622 | TEVA PHARMS USA |
GLATIRAMER ACETATE | GLATIRAMER ACETATE | 20MG/ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 091646 | MYLAN |
GLATOPA | GLATIRAMER ACETATE | 20MG/ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 090218 | SANDOZ |