Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202104
Company: UPSHER SMITH LABS
Company: UPSHER SMITH LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
| MORPHINE SULFATE | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| MORPHINE SULFATE | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| MORPHINE SULFATE | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| MORPHINE SULFATE | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| MORPHINE SULFATE | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 06/03/2013 | 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 |
|---|---|---|---|---|---|
| 10/31/2024 | SUPPL-25 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-23 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/15/2021 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 12/15/2021 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2021 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-11 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 05/26/2017 | SUPPL-9 | REMS-Modified |
Label is not available on this site. |
||
| 09/30/2016 | SUPPL-7 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/20/2016 | SUPPL-6 | REMS-Modified |
Label is not available on this site. |
||
| 06/26/2015 | SUPPL-5 | REMS-Modified |
Label is not available on this site. |
||
| 08/19/2014 | SUPPL-4 | REMS-Modified |
Label is not available on this site. |
||
| 07/15/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
MORPHINE SULFATE
CAPSULE, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202104 | UPSHER SMITH LABS |
CAPSULE, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202104 | UPSHER SMITH LABS |
CAPSULE, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202104 | UPSHER SMITH LABS |
CAPSULE, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202104 | UPSHER SMITH LABS |
CAPSULE, EXTENDED RELEASE;ORAL; 80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202104 | UPSHER SMITH LABS |
CAPSULE, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202104 | UPSHER SMITH LABS |