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| ELAVIL | AMITRIPTYLINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ELAVIL | AMITRIPTYLINE HYDROCHLORIDE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ELAVIL | AMITRIPTYLINE HYDROCHLORIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ELAVIL | AMITRIPTYLINE HYDROCHLORIDE | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ELAVIL | AMITRIPTYLINE HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ELAVIL | AMITRIPTYLINE HYDROCHLORIDE | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 04/07/1961 | 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 |
|---|---|---|---|---|---|
| 07/29/2003 | SUPPL-93 | 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-92 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12704S45LTR.PDF |
| 01/22/2001 | SUPPL-91 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/05/2000 | SUPPL-90 | Labeling |
Label is not available on this site. |
||
| 12/24/1998 | SUPPL-89 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/2000 | SUPPL-88 | Labeling |
Label is not available on this site. |
||
| 12/30/1996 | SUPPL-87 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/05/2000 | SUPPL-86 | Labeling |
Label is not available on this site. |
||
| 07/13/1995 | SUPPL-85 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/05/2000 | SUPPL-84 | Labeling |
Label is not available on this site. |
||
| 06/01/1994 | SUPPL-83 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/01/1994 | SUPPL-82 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/24/1991 | SUPPL-81 | Labeling |
Label is not available on this site. |
||
| 07/28/1989 | SUPPL-80 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1991 | SUPPL-79 | Labeling |
Label is not available on this site. |
||
| 04/08/1988 | SUPPL-78 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/12/1988 | SUPPL-77 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/24/1991 | SUPPL-76 | Labeling |
Label is not available on this site. |
||
| 02/26/1988 | SUPPL-75 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/02/1986 | SUPPL-74 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/10/1986 | SUPPL-73 | Labeling |
Label is not available on this site. |
||
| 09/20/1985 | SUPPL-72 | Labeling |
Label is not available on this site. |
||
| 09/13/1984 | SUPPL-71 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/15/1984 | SUPPL-70 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/07/1984 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1983 | SUPPL-68 | Labeling |
Label is not available on this site. |
||
| 05/26/1983 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1984 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 05/03/1983 | SUPPL-64 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/25/1981 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1981 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 09/03/1980 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 06/23/1980 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-58 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/04/1981 | SUPPL-57 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1980 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 01/29/1980 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 11/06/1979 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/1980 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/1978 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/01/1977 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/02/1976 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/1976 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 08/02/1976 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/28/1976 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 09/18/1975 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 09/18/1975 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 09/17/1975 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/1975 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/09/1981 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |