Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 203883
Company: HOSPIRA INC
Company: HOSPIRA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ADENOSINE | ADENOSINE | 60MG/20ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
ADENOSINE | ADENOSINE | 90MG/30ML (3MG/ML) | SOLUTION;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
03/24/2014 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/17/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
ADENOSINE
SOLUTION;INTRAVENOUS; 60MG/20ML (3MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ADENOSINE | ADENOSINE | 60MG/20ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 090450 | AKORN |
ADENOSINE | ADENOSINE | 60MG/20ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205331 | AUROBINDO PHARMA LTD |
ADENOSINE | ADENOSINE | 60MG/20ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 202313 | EMCURE PHARMS LTD |
ADENOSINE | ADENOSINE | 60MG/20ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 077897 | FRESENIUS KABI USA |
ADENOSINE | ADENOSINE | 60MG/20ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 203883 | HOSPIRA INC |
ADENOSINE | ADENOSINE | 60MG/20ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 090212 | MYLAN ASI |
ADENOSINE | ADENOSINE | 60MG/20ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 077425 | TEVA PHARMS USA |
SOLUTION;INTRAVENOUS; 90MG/30ML (3MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ADENOSINE | ADENOSINE | 90MG/30ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 090450 | AKORN |
ADENOSINE | ADENOSINE | 90MG/30ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205331 | AUROBINDO PHARMA LTD |
ADENOSINE | ADENOSINE | 90MG/30ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 202313 | EMCURE PHARMS LTD |
ADENOSINE | ADENOSINE | 90MG/30ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 077897 | FRESENIUS KABI USA |
ADENOSINE | ADENOSINE | 90MG/30ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 203883 | HOSPIRA INC |
ADENOSINE | ADENOSINE | 90MG/30ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 090212 | MYLAN ASI |
ADENOSINE | ADENOSINE | 90MG/30ML (3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 077425 | TEVA PHARMS USA |
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