Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073556
Company: DR REDDYS LABS SA
Company: DR REDDYS LABS SA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 03/30/1992 | 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 |
|---|---|---|---|---|---|
| 02/21/2020 | SUPPL-55 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/15/2015 | SUPPL-52 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/15/2015 | SUPPL-50 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/20/2008 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 07/03/2007 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 04/12/2007 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 11/01/2006 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/26/2005 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 01/04/2002 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/25/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1997 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/05/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/25/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
NORTRIPTYLINE HYDROCHLORIDE
CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 073556 | DR REDDYS LABS SA |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075520 | TARO |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 074132 | TEVA |
| PAMELOR | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 018013 | SPECGX LLC |
CAPSULE;ORAL; EQ 10MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 073556 | DR REDDYS LABS SA |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075520 | TARO |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 074132 | TEVA |
| PAMELOR | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 018013 | SPECGX LLC |
CAPSULE;ORAL; EQ 25MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 073556 | DR REDDYS LABS SA |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075520 | TARO |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 074132 | TEVA |
| PAMELOR | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 018013 | SPECGX LLC |
CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 073556 | DR REDDYS LABS SA |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075520 | TARO |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 074132 | TEVA |
| PAMELOR | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 018013 | SPECGX LLC |