Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 013296
Company: 3M
Company: 3M
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DUO-MEDIHALER | ISOPROTERENOL HYDROCHLORIDE; PHENYLEPHRINE BITARTRATE | 0.16MG/INH;0.24MG/INH | AEROSOL, METERED;INHALATION | Discontinued | 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 |
---|---|---|---|---|---|---|---|
08/20/1973 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/23/1994 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
02/27/1987 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
05/21/1984 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
03/05/1982 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/13/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |