Drugs@FDA: FDA-Approved Drugs
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Discontinued | 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 |
---|---|---|---|---|---|---|---|
08/11/1981 | 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 |
---|---|---|---|---|---|
11/08/2016 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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03/30/2016 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
09/25/2014 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087329Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/087329Orig1s020ltr.pdf | |
06/04/2014 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087329Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/087329Orig1s019ltr.pdf | |
12/05/2002 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
06/24/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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07/05/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/23/1993 | SUPPL-9 | Labeling |
Label is not available on this site. |
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09/23/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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03/20/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
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12/13/1984 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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10/02/1984 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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10/02/1984 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/13/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/25/2014 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087329Orig1s020lbl.pdf | |
06/04/2014 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087329Orig1s019lbl.pdf |