Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076500
Company: HIKMA
Company: HIKMA
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 |
---|---|---|---|---|---|---|---|
06/16/2004 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76500ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076500.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/06/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
11/21/2006 | SUPPL-1 | Labeling |
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 |