Drugs@FDA: FDA-Approved Drugs
Company: ASTRAZENECA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
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DURANEST | ETIDOCAINE HYDROCHLORIDE | 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
DURANEST | EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE | 0.005MG/ML;0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
DURANEST | ETIDOCAINE HYDROCHLORIDE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
DURANEST | EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE | 0.005MG/ML;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
DURANEST | EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE | 0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
08/30/1976 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
03/02/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
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05/31/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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03/02/1999 | SUPPL-11 | Labeling |
Label is not available on this site. |
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10/04/1990 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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04/08/1987 | SUPPL-9 | Labeling |
Label is not available on this site. |
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03/06/1986 | SUPPL-8 | Labeling |
Label is not available on this site. |
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08/07/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |
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08/07/1985 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/28/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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01/29/1987 | SUPPL-4 | Labeling |
Label is not available on this site. |
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07/13/1982 | SUPPL-3 | Labeling |
Label is not available on this site. |
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07/13/1982 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/29/1979 | SUPPL-1 | Labeling |
Label is not available on this site. |