Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211452
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MORPHINE SULFATE | MORPHINE SULFATE | 2MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
MORPHINE SULFATE | MORPHINE SULFATE | 4MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
MORPHINE SULFATE | MORPHINE SULFATE | 8MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
MORPHINE SULFATE | MORPHINE SULFATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
MORPHINE SULFATE | MORPHINE SULFATE | 15MG/ML | INJECTABLE;INJECTION | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
01/12/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211452Orig1s000ltr.pdf |
MORPHINE SULFATE
INJECTABLE;INJECTION; 2MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MORPHINE SULFATE | MORPHINE SULFATE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211452 | HIKMA |
MORPHINE SULFATE | MORPHINE SULFATE | 2MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 202515 | HOSPIRA INC |
INJECTABLE;INJECTION; 4MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MORPHINE SULFATE | MORPHINE SULFATE | 4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205758 | HIKMA |
MORPHINE SULFATE | MORPHINE SULFATE | 4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211452 | HIKMA |
MORPHINE SULFATE | MORPHINE SULFATE | 4MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 202515 | HOSPIRA INC |
INJECTABLE;INJECTION; 8MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MORPHINE SULFATE | MORPHINE SULFATE | 8MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205758 | HIKMA |
MORPHINE SULFATE | MORPHINE SULFATE | 8MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211452 | HIKMA |
MORPHINE SULFATE | MORPHINE SULFATE | 8MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 202515 | HOSPIRA INC |
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 |