Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078591
Company: HOSPIRA INC
Company: HOSPIRA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 10MG/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 |
---|---|---|---|---|---|---|---|
06/17/2008 | 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 |
---|---|---|---|---|---|
08/18/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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08/18/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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02/18/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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02/18/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
HYDROMORPHONE HYDROCHLORIDE
INJECTABLE;INJECTION; 10MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078591 | HOSPIRA INC |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078228 | RISING |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078261 | RISING |