Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206573
Company: PHARM ASSOC
Company: PHARM ASSOC
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 |
MORPHINE SULFATE | MORPHINE SULFATE | 10MG/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 |
---|---|---|---|---|---|---|---|
11/14/2016 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/08/2023 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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05/08/2023 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
05/08/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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05/08/2023 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
05/08/2023 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-1 | REMS - PROPOSAL - D-N-A |
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 | 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 |
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 |