Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091646
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GLATIRAMER ACETATE | 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 |
---|---|---|---|---|---|---|---|
10/03/2017 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/091646Orig1s000ltr.pdf |
GLATIRAMER ACETATE
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 INC |
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