Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086009
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | AB | No | No |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | AB | No | No |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 04/10/1978 | 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 |
|---|---|---|---|---|---|
| 06/24/2025 | SUPPL-71 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2016 | SUPPL-67 | Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-66 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/21/2007 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 04/14/2008 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 07/11/2007 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 07/08/2005 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 05/07/2002 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 01/29/2001 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 03/12/1999 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1999 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1995 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 04/24/1995 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 06/01/1995 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1995 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1995 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/24/1993 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1993 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 11/14/1991 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 08/17/1989 | SUPPL-34 | Bioequivalence |
Label is not available on this site. |
||
| 08/17/1989 | SUPPL-33 | Bioequivalence |
Label is not available on this site. |
||
| 07/11/1989 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1989 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1988 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1986 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/23/1984 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1984 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/1983 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/1983 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/04/1982 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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 | 212654 | AIPING PHARM INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 086009 | AUROBINDO PHARMA USA |
| 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 RESEARCH |
| 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 | 218389 | UNIQUE PHARM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | 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 | 212654 | AIPING PHARM INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 086009 | AUROBINDO PHARMA USA |
| 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 RESEARCH |
| 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 | 218389 | UNIQUE PHARM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | 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 | 212654 | AIPING PHARM INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 086009 | AUROBINDO PHARMA USA |
| 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 RESEARCH |
| 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 | 218389 | UNIQUE PHARM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | 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 | 212654 | AIPING PHARM INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 086009 | AUROBINDO PHARMA USA |
| 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 RESEARCH |
| 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 | 218389 | UNIQUE PHARM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | 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 | 212654 | AIPING PHARM INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 086009 | AUROBINDO PHARMA USA |
| 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 RESEARCH |
| 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 | 218389 | UNIQUE PHARM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | 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 | 212654 | AIPING PHARM INC |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 086009 | AUROBINDO PHARMA USA |
| 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 RESEARCH |
| 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 | 218389 | UNIQUE PHARM |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 210086 | ZYDUS PHARMS |