Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077839
Company: RITEDOSE CORP
Company: RITEDOSE CORP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.083% BASE | SOLUTION;INHALATION | Prescription | AN | 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 |
---|---|---|---|---|---|---|---|
12/16/2008 | 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 |
---|---|---|---|---|---|
01/28/2013 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
ALBUTEROL SULFATE
SOLUTION;INHALATION; EQ 0.083% BASE
TE Code = AN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.083% BASE | SOLUTION;INHALATION | Prescription | No | AN | 206224 | LUOXIN AUROVITAS |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.083% BASE | SOLUTION;INHALATION | Prescription | No | AN | 074880 | NEPHRON |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.083% BASE | SOLUTION;INHALATION | Prescription | No | AN | 077839 | RITEDOSE CORP |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.083% BASE | SOLUTION;INHALATION | Prescription | No | AN | 207857 | SUN PHARM |