Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204393
Company: PIRAMAL CRITICAL
Company: PIRAMAL CRITICAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MITIGO | MORPHINE SULFATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
MITIGO | MORPHINE SULFATE | 25MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
07/16/2018 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204393Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/06/2021 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
MITIGO
INJECTABLE;INJECTION; 10MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
INFUMORPH | MORPHINE SULFATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018565 | HIKMA |
MITIGO | MORPHINE SULFATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204393 | PIRAMAL CRITICAL |
MORPHINE SULFATE | MORPHINE SULFATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205758 | HIKMA |
MORPHINE SULFATE | MORPHINE SULFATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211452 | HIKMA |
MORPHINE SULFATE | MORPHINE SULFATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 202515 | HOSPIRA INC |
INJECTABLE;INJECTION; 25MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
INFUMORPH | MORPHINE SULFATE | 25MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018565 | HIKMA |
MITIGO | MORPHINE SULFATE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204393 | PIRAMAL CRITICAL |