Drugs@FDA: FDA-Approved Drugs
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ELAVIL | AMITRIPTYLINE HYDROCHLORIDE | 10MG/ML | 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 |
|---|---|---|---|---|---|---|---|
| 04/11/1961 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 07/29/2003 | SUPPL-46 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12703slr093,12704slr046ltr.pdf |
| 03/27/2001 | SUPPL-45 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12704S45LTR.PDF |
| 04/05/2000 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 12/24/1998 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/05/2000 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 04/05/2000 | SUPPL-41 | Labeling |
Label is not available on this site. |
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| 04/05/2000 | SUPPL-40 | Labeling |
Label is not available on this site. |
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| 04/05/2000 | SUPPL-39 | Labeling |
Label is not available on this site. |
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| 07/28/1989 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1991 | SUPPL-35 | Labeling |
Label is not available on this site. |
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| 12/12/1988 | SUPPL-34 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 06/24/1991 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 07/10/1986 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 09/20/1985 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 03/15/1983 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 05/21/1984 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 10/02/1995 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/25/1981 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/23/1981 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 09/03/1980 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 06/23/1980 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 03/02/1981 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1980 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/09/1981 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |