Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012703
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ELAVIL AMITRIPTYLINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ELAVIL AMITRIPTYLINE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ELAVIL AMITRIPTYLINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ELAVIL AMITRIPTYLINE HYDROCHLORIDE 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ELAVIL AMITRIPTYLINE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ELAVIL AMITRIPTYLINE HYDROCHLORIDE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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.

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