Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210968
Company: EUGIA PHARMA
Company: EUGIA PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OLANZAPINE | OLANZAPINE | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | 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 |
---|---|---|---|---|---|---|---|
10/22/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
OLANZAPINE
INJECTABLE;INTRAMUSCULAR; 10MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OLANZAPINE | OLANZAPINE | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | No | AP | 201741 | AM REGENT |
OLANZAPINE | OLANZAPINE | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | No | AP | 217466 | ASPIRO |
OLANZAPINE | OLANZAPINE | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | No | AP | 210968 | EUGIA PHARMA |
OLANZAPINE | OLANZAPINE | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | No | AP | 201588 | SANDOZ INC |
ZYPREXA | OLANZAPINE | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | Yes | AP | 021253 | CHEPLAPHARM |