Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIAZEPAM INTENSOL | DIAZEPAM | 5MG/ML | CONCENTRATE;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
04/03/1987 | 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 |
---|---|---|---|---|---|
01/17/2023 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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02/05/2021 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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07/27/2020 | SUPPL-16 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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05/02/2016 | SUPPL-14 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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04/20/2001 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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09/21/2000 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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12/09/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
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08/28/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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12/09/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
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06/11/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
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04/20/1989 | SUPPL-2 | Bioequivalence |
Label is not available on this site. |
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01/26/1990 | SUPPL-1 | Labeling |
Label is not available on this site. |
DIAZEPAM INTENSOL
CONCENTRATE;ORAL; 5MG/ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIAZEPAM | DIAZEPAM | 5MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 204433 | CHARTWELL MOLECULAR |
DIAZEPAM INTENSOL | DIAZEPAM | 5MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 071415 | HIKMA |