Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/03/1989 | 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 |
---|---|---|---|---|---|
08/27/2024 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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12/15/2023 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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12/01/2023 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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10/16/2019 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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12/16/2016 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/16/2016 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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11/30/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
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07/12/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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01/24/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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01/24/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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10/03/1996 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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04/26/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
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02/28/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
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07/25/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
NALBUPHINE HYDROCHLORIDE
INJECTABLE;INJECTION; 20MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 070916 | HOSPIRA |
NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 070918 | HOSPIRA |