Drugs@FDA: FDA-Approved Drugs
Company: LEDERLE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DECLOMYCIN | DEMECLOCYCLINE HYDROCHLORIDE | 150MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 01/14/1960 | 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 |
|---|---|---|---|---|---|
| 02/28/1974 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/01/1973 | SUPPL-60 | Labeling |
Label is not available on this site. |
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| 03/26/1982 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/1979 | SUPPL-58 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/26/1976 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/09/1976 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/10/1975 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/05/1972 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 02/10/1972 | SUPPL-53 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/03/1969 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/12/1967 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 07/13/1967 | SUPPL-49 | Labeling |
Label is not available on this site. |
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| 07/13/1967 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 01/05/1966 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 09/28/1966 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 10/19/1965 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/03/1965 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/03/1965 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/1965 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1965 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/25/1965 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/09/1965 | SUPPL-39 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/20/1972 | SUPPL-38 | Labeling |
Label is not available on this site. |
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| 07/13/1971 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 09/14/1967 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 06/16/1967 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 12/28/1965 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 09/03/1965 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 03/16/1965 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 08/13/1964 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 06/09/1964 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 01/15/1964 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 01/14/1964 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 11/12/1963 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 07/10/1963 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 05/24/1963 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 01/11/1962 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 10/30/1961 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 02/15/1960 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/02/1965 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/21/1963 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/1961 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/1961 | SUPPL-17 | Efficacy-New Indication |
Label is not available on this site. |
||
| 08/21/1961 | SUPPL-16 | Efficacy-New Indication |
Label is not available on this site. |
||
| 06/23/1961 | SUPPL-15 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/19/1960 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/29/1960 | SUPPL-13 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/12/1960 | SUPPL-12 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 03/04/1960 | SUPPL-11 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 11/20/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/20/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/09/1986 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 06/21/1983 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |