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. |
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| 05/21/1984 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/05/1982 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/13/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |