Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203518
Company: TRIS PHARMA INC
Company: TRIS PHARMA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MORPHINE SULFATE | MORPHINE SULFATE | 10MG/5ML | SOLUTION;ORAL | Prescription | AA | No | No |
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 |
---|---|---|---|---|---|---|---|
05/12/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203518Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/18/2018 | SUPPL-4 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
MORPHINE SULFATE
SOLUTION;ORAL; 10MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MORPHINE SULFATE | MORPHINE SULFATE | 10MG/5ML | SOLUTION;ORAL | Prescription | Yes | AA | 022195 | HIKMA |
MORPHINE SULFATE | MORPHINE SULFATE | 10MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 206573 | PHARM ASSOC |
MORPHINE SULFATE | MORPHINE SULFATE | 10MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 206308 | RHODES PHARMS |
MORPHINE SULFATE | MORPHINE SULFATE | 10MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 203518 | TRIS PHARMA INC |
MORPHINE SULFATE | MORPHINE SULFATE | 10MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 211454 | WINDER LABS LLC |
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 | 206573 | PHARM ASSOC |
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 |