Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017549
Company: MERIDIAN MEDCL TECHN
Company: MERIDIAN MEDCL TECHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIDOPEN | LIDOCAINE HYDROCHLORIDE | 10% | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/28/1975 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 10/31/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/2000 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/08/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/21/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/18/1997 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/09/1997 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/06/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/10/1993 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/23/1988 | SUPPL-12 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 12/10/1986 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 04/16/1984 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 01/11/1978 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 03/17/1977 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 10/18/1976 | SUPPL-3 | Efficacy |
Label is not available on this site. |
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| 12/04/1975 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/24/1975 | SUPPL-1 | Labeling |
Label is not available on this site. |