Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085968
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | AB | Yes | No |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AB | Yes | No |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | AB | Yes | No |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 11/29/1977 | 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-98 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-96 | 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-90 | Labeling |
Label is not available on this site. |
||
| 06/29/2007 | SUPPL-89 | Labeling |
Label is not available on this site. |
||
| 06/09/2005 | SUPPL-87 | Labeling |
Label is not available on this site. |
||
| 12/16/2002 | SUPPL-86 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/25/2001 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
| 03/23/2001 | SUPPL-84 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/2000 | SUPPL-83 | Labeling |
Label is not available on this site. |
||
| 05/05/1999 | SUPPL-82 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1998 | SUPPL-81 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/1996 | SUPPL-80 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/1996 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/1995 | SUPPL-78 | Labeling |
Label is not available on this site. |
||
| 02/01/1995 | SUPPL-77 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1993 | SUPPL-76 | Labeling |
Label is not available on this site. |
||
| 12/15/1992 | SUPPL-75 | Labeling |
Label is not available on this site. |
||
| 07/17/1987 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1987 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1987 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1987 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1987 | 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. |
||
| 07/17/1987 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1985 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1985 | 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. |
||
| 10/25/1983 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1983 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1983 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1983 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1983 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1982 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1982 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1982 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1982 | SUPPL-38 | 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-96 | 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; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 202446 | ACCORD HLTHCARE |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 216243 | CHEMISTRY HLTH |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 213999 | MANKIND PHARMA |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 089400 | MUTUAL PHARM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 217411 | RISING |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 215376 | RUBICON |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 085968 | SANDOZ |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 089399 | SUN PHARM INDS INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 214548 | UNICHEM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 210086 | ZYDUS PHARMS |
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 | 216243 | CHEMISTRY HLTH |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 213999 | MANKIND PHARMA |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 217411 | RISING |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 215376 | RUBICON |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 085968 | SANDOZ |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 089399 | SUN PHARM INDS INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 214548 | UNICHEM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 210086 | ZYDUS PHARMS |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 202446 | ACCORD HLTHCARE |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 216243 | CHEMISTRY HLTH |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 213999 | MANKIND PHARMA |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 089402 | MUTUAL PHARM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 217411 | RISING |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 215376 | RUBICON |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 085968 | SANDOZ |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 089399 | SUN PHARM INDS INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 214548 | UNICHEM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 210086 | ZYDUS PHARMS |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 202446 | ACCORD HLTHCARE |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 216243 | CHEMISTRY HLTH |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 213999 | MANKIND PHARMA |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 217411 | RISING |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 215376 | RUBICON |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 085968 | SANDOZ |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 089399 | SUN PHARM INDS INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 214548 | UNICHEM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 210086 | ZYDUS PHARMS |
TABLET;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 202446 | ACCORD HLTHCARE |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 216243 | CHEMISTRY HLTH |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 213999 | MANKIND PHARMA |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 217411 | RISING |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 215376 | RUBICON |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | Yes | AB | 085968 | SANDOZ |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 085970 | SANDOZ |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 089399 | SUN PHARM INDS INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 214548 | UNICHEM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 210086 | ZYDUS PHARMS |
TABLET;ORAL; 75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 202446 | ACCORD HLTHCARE |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 216243 | CHEMISTRY HLTH |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 213999 | MANKIND PHARMA |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 217411 | RISING |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 215376 | RUBICON |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | Yes | AB | 085968 | SANDOZ |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 089399 | SUN PHARM INDS INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 214548 | UNICHEM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 210086 | ZYDUS PHARMS |