Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017508
Company: ABRAXIS PHARM
Company: ABRAXIS PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 20% | 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 |
|---|---|---|---|---|---|---|---|
| 10/27/1976 | 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 |
|---|---|---|---|---|---|
| 12/07/1987 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 03/02/1981 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 12/13/1982 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 01/08/1980 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 07/10/1979 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 11/01/1978 | SUPPL-1 | Labeling |
Label is not available on this site. |