Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090574
Company: MYLAN INSTITUTIONAL
Company: MYLAN INSTITUTIONAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
COSYNTROPIN | COSYNTROPIN | 0.25MG/VIAL | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
12/17/2009 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090574s000ltr.pdf |
COSYNTROPIN
INJECTABLE;INJECTION; 0.25MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CORTROSYN | COSYNTROPIN | 0.25MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 016750 | AMPHASTAR PHARMS INC |
COSYNTROPIN | COSYNTROPIN | 0.25MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090574 | MYLAN INSTITUTIONAL |
COSYNTROPIN | COSYNTROPIN | 0.25MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 202147 | SANDOZ |