Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019753
Company: SHIRE
Company: SHIRE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ETHMOZINE | MORICIZINE HYDROCHLORIDE | 200MG | TABLET;ORAL | Discontinued | None | No | No |
| ETHMOZINE | MORICIZINE HYDROCHLORIDE | 250MG | TABLET;ORAL | Discontinued | None | No | No |
| ETHMOZINE | MORICIZINE HYDROCHLORIDE | 300MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 06/19/1990 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/11/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 07/08/1992 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/22/1992 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 09/16/1992 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 09/20/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 08/23/1990 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |