Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 014763
Company: ASTRAZENECA
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CITANEST | PRILOCAINE HYDROCHLORIDE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| CITANEST | PRILOCAINE HYDROCHLORIDE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| CITANEST | PRILOCAINE HYDROCHLORIDE | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| CITANEST FORTE | EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE | 0.005MG/ML;4% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CITANEST PLAIN | PRILOCAINE HYDROCHLORIDE | 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 11/18/1965 | 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 |
|---|---|---|---|---|---|
| 12/01/2000 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/31/1996 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/09/1997 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 03/11/1987 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 03/21/1986 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 08/29/1986 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 06/28/1982 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/22/1985 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 03/24/1985 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 08/31/1981 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 07/27/1982 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 07/27/1982 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/31/1981 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/08/1981 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/29/1979 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 04/04/1979 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 04/09/1979 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/03/1976 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 03/03/1976 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |