Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078523
Company: HIKMA FARMACEUTICA
Company: HIKMA FARMACEUTICA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VALPROATE SODIUM | VALPROATE SODIUM | EQ 100MG BASE/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 |
---|---|---|---|---|---|---|---|
02/17/2010 | 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 |
---|---|---|---|---|---|
04/21/2020 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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04/21/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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04/21/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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04/21/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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04/21/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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12/15/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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12/15/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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12/15/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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12/15/2014 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
VALPROATE SODIUM
INJECTABLE;INJECTION; EQ 100MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VALPROATE SODIUM | VALPROATE SODIUM | EQ 100MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076539 | FRESENIUS KABI USA |
VALPROATE SODIUM | VALPROATE SODIUM | EQ 100MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078523 | HIKMA FARMACEUTICA |
VALPROATE SODIUM | VALPROATE SODIUM | EQ 100MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076295 | SAGENT |