Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017702
Company: INTL MEDICATION
Company: INTL MEDICATION
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 20% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 4% | 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 |
|---|---|---|---|---|---|---|---|
| 12/20/1976 | 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 |
|---|---|---|---|---|---|
| 10/18/1995 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1993 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 12/11/1992 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/06/1992 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/17/1993 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/14/1992 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/11/1992 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/12/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/17/1993 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/26/1986 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 07/11/1978 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 07/11/1978 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 08/24/1977 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 08/24/1977 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |