Drugs@FDA: FDA-Approved Drugs
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MUCOMYST | ACETYLCYSTEINE | 20% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INHALATION, ORAL | Discontinued | None | Yes | No |
| MUCOMYST | ACETYLCYSTEINE | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INHALATION, ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 09/14/1963 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/24/2001 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/19/1997 | SUPPL-52 | Labeling |
Label is not available on this site. |
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| 04/21/1997 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/05/1991 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/13/2009 | SUPPL-49 | Labeling |
Label is not available on this site. |
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| 07/13/1993 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/13/2009 | SUPPL-46 | Efficacy-New Route Of Administration |
Label is not available on this site. |
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| 01/16/1987 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/18/1986 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/02/1983 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/13/2009 | SUPPL-37 | Labeling |
Label is not available on this site. |
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| 11/20/1981 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/31/1985 | SUPPL-35 | Efficacy |
Label is not available on this site. |
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| 01/10/1980 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/18/1979 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/23/1979 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/19/1978 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/14/1978 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/01/1978 | SUPPL-29 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/013601Orig1s029.pdf |
| 02/08/1980 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/08/1977 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/06/1977 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/15/1977 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/02/1975 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/18/1975 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/10/1975 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/19/1974 | SUPPL-18 |
Label is not available on this site. |