Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085966
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/21/1977 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/25/2016 SUPPL-97 Labeling-Package Insert

Label is not available on this site.

07/17/2014 SUPPL-95 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/085966s095,085969s084,085968s096,085971s075,085967s076,085970s072lbl.pdf
11/13/2007 SUPPL-89 Labeling

Label is not available on this site.

06/29/2007 SUPPL-88 Labeling

Label is not available on this site.

06/09/2005 SUPPL-86 Labeling

Label is not available on this site.

12/16/2002 SUPPL-84 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/2001 SUPPL-83 Labeling

Label is not available on this site.

03/23/2001 SUPPL-82 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/2000 SUPPL-81 Labeling

Label is not available on this site.

10/05/1999 SUPPL-80 Manufacturing (CMC)

Label is not available on this site.

05/05/1999 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

05/28/1998 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

11/18/1996 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

04/17/1996 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

04/10/1995 SUPPL-75 Labeling

Label is not available on this site.

02/01/1995 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

08/27/1993 SUPPL-73 Labeling

Label is not available on this site.

12/15/1992 SUPPL-72 Labeling

Label is not available on this site.

07/17/1987 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

07/17/1987 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

07/17/1987 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

07/17/1987 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

07/17/1987 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

07/17/1987 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

07/17/1987 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

04/27/1987 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

01/08/1987 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

01/08/1987 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

01/08/1987 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

03/01/1985 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

03/01/1985 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

01/25/1984 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

07/27/1983 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

07/27/1983 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

07/27/1983 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

03/21/1983 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

07/23/1982 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

07/23/1982 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

02/02/1982 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

02/02/1982 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

03/21/1983 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/17/2014 SUPPL-95 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/085966s095,085969s084,085968s096,085971s075,085967s076,085970s072lbl.pdf

AMITRIPTYLINE HYDROCHLORIDE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 202446 ACCORD HLTHCARE
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 086009 MYLAN
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 085966 SANDOZ
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040218 VINTAGE PHARMS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 210086 ZYDUS PHARMS USA INC

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