Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076749
Company: NEPHRON
Company: NEPHRON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | EQ 0.083% BASE;0.017% | SOLUTION;INHALATION | Prescription | AN | No | Yes |
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | 0.5MG; 0.017% | SOLUTION; INHALATION | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
12/31/2007 | 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 |
---|---|---|---|---|---|
08/13/2012 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
12/13/2011 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
09/16/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
SOLUTION;INHALATION; EQ 0.083% BASE;0.017%
TE Code = AN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | EQ 0.083% BASE;0.017% | SOLUTION;INHALATION | Prescription | No | AN | 077559 | CIPLA |
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | EQ 0.083% BASE;0.017% | SOLUTION;INHALATION | Prescription | No | AN | 076749 | NEPHRON |
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | EQ 0.083% BASE;0.017% | SOLUTION;INHALATION | Prescription | No | AN | 202496 | RITEDOSE CORP |
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | EQ 0.083% BASE;0.017% | SOLUTION;INHALATION | Prescription | No | AN | 207875 | SUN PHARM |
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
There are no Therapeutic Equivalents.