Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016803
Company: STERLING
Company: STERLING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRONKAID MIST | EPINEPHRINE | 0.25MG/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 |
|---|---|---|---|---|---|---|---|
| 08/11/1969 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 09/15/1995 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/23/1988 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/21/1988 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1988 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/25/1986 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/31/1983 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/16/1985 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1980 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/21/1978 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/28/1978 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/02/1975 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |