Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202348
Company: SPECGX LLC
Company: SPECGX LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG/5ML | SOLUTION;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 07/15/2011 | 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 |
|---|---|---|---|---|---|
| 02/24/2020 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/24/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-6 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 02/24/2020 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/04/2015 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
MORPHINE SULFATE
SOLUTION;ORAL; 100MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG/5ML | SOLUTION;ORAL | Prescription | Yes | AA | 022195 | HIKMA |
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 201574 | PADAGIS US |
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 206308 | RHODES PHARMS |
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 202348 | SPECGX LLC |
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 203518 | TRIS PHARMA INC |
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 211454 | WINDER LABS LLC |