Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075693
Company: RITEDOSE CORP
Company: RITEDOSE CORP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IPRATROPIUM BROMIDE | IPRATROPIUM BROMIDE | 0.02% | SOLUTION;INHALATION | Prescription | AN | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/26/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75693ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/20/2013 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
10/21/2011 | SUPPL-15 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
12/17/2002 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
05/07/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/24/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
10/11/2001 | SUPPL-1 | Labeling |
Label is not available on this site. |
IPRATROPIUM BROMIDE
SOLUTION;INHALATION; 0.02%
TE Code = AN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IPRATROPIUM BROMIDE | IPRATROPIUM BROMIDE | 0.02% | SOLUTION;INHALATION | Prescription | No | AN | 206543 | LUOXIN AUROVITAS |
IPRATROPIUM BROMIDE | IPRATROPIUM BROMIDE | 0.02% | SOLUTION;INHALATION | Prescription | No | AN | 075562 | NEPHRON |
IPRATROPIUM BROMIDE | IPRATROPIUM BROMIDE | 0.02% | SOLUTION;INHALATION | Prescription | No | AN | 075693 | RITEDOSE CORP |
IPRATROPIUM BROMIDE | IPRATROPIUM BROMIDE | 0.02% | SOLUTION;INHALATION | Prescription | No | AN | 207903 | SUN PHARM |