Drugs@FDA: FDA-Approved Drugs
Company: DEY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MUCOSIL-20 | ACETYLCYSTEINE | 20% | SOLUTION;INHALATION, ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/14/1986 | 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 |
|---|---|---|---|---|---|
| 03/21/2000 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/21/2000 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/14/2001 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/1999 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 11/25/1998 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 02/20/1998 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 09/05/1997 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/24/1996 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1992 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 10/26/1990 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 07/19/1990 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/01/1989 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/01/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 04/20/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1988 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/20/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 01/22/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1987 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/16/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |