Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206778
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ADENOSINE | ADENOSINE | 3MG/ML | 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 |
---|---|---|---|---|---|---|---|
02/16/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ADENOSINE
INJECTABLE;INJECTION; 3MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ADENOSINE | ADENOSINE | 3MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077133 | FRESENIUS KABI USA |
ADENOSINE | ADENOSINE | 3MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205568 | FRESENIUS KABI USA |
ADENOSINE | ADENOSINE | 3MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077283 | GLAND PHARMA LTD |
ADENOSINE | ADENOSINE | 3MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206778 | GLAND PHARMA LTD |
ADENOSINE | ADENOSINE | 3MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076404 | HIKMA |
ADENOSINE | ADENOSINE | 3MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076500 | HIKMA |
ADENOSINE | ADENOSINE | 3MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078686 | MYLAN LABS LTD |
ADENOSINE | ADENOSINE | 3MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078076 | RISING |