Drugs@FDA: FDA-Approved Drugs
Company: DR REDDYS LABS SA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIAZEPAM | DIAZEPAM | 5MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
02/03/1987 | 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 |
---|---|---|---|---|---|
08/02/2021 | SUPPL-38 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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08/02/2021 | SUPPL-35 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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03/09/2015 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
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08/06/2008 | SUPPL-24 | Labeling |
Label is not available on this site. |
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04/25/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/21/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/17/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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07/02/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
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05/31/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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06/29/1990 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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07/10/1990 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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05/04/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
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08/11/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
DIAZEPAM
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIAZEPAM | DIAZEPAM | 5MG | TABLET;ORAL | Prescription | No | AB | 217843 | AUROBINDO PHARMA LTD |
DIAZEPAM | DIAZEPAM | 5MG | TABLET;ORAL | Prescription | No | AB | 071135 | DR REDDYS LABS SA |
DIAZEPAM | DIAZEPAM | 5MG | TABLET;ORAL | Prescription | No | AB | 071321 | IVAX SUB TEVA PHARMS |
DIAZEPAM | DIAZEPAM | 5MG | TABLET;ORAL | Prescription | No | AB | 070325 | MYLAN |
DIAZEPAM | DIAZEPAM | 5MG | TABLET;ORAL | Prescription | No | AB | 077749 | STRIDES PHARMA |
VALIUM | DIAZEPAM | 5MG | TABLET;ORAL | Prescription | Yes | AB | 013263 | WAYLIS THERAP |