Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MORPHINE SULFATE | MORPHINE SULFATE | 0.5MG/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 |
---|---|---|---|---|---|---|---|
09/30/1992 | 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 |
---|---|---|---|---|---|
02/10/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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10/25/2002 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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03/22/2001 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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03/22/2001 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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07/22/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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01/07/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
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01/07/2000 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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10/03/1996 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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10/22/1996 | SUPPL-3 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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11/09/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
MORPHINE SULFATE
INJECTABLE;INJECTION; 0.5MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DURAMORPH PF | MORPHINE SULFATE | 0.5MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018565 | HIKMA |
MORPHINE SULFATE | MORPHINE SULFATE | 0.5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 073509 | HOSPIRA |