Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075735
Company: LUPIN
Company: LUPIN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 07/11/2001 | 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 |
|---|---|---|---|---|---|
| 01/23/2026 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/23/2026 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2024 | SUPPL-22 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 01/03/2024 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2024 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/09/2019 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/20/2018 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-13 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 04/20/2017 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/20/2017 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/07/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
TABLET;ORAL; EQ 0.5MG BASE;EQ 50MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 075735 | LUPIN |
| NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 075523 | SUN PHARM INDS LTD |
| NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 074736 | WATSON LABS |