Drugs@FDA: FDA-Approved Drugs
Company: UNITED RES LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXAZEPAM | OXAZEPAM | 30MG | CAPSULE;ORAL | Prescription | AB | No | No |
OXAZEPAM | OXAZEPAM | 10MG | CAPSULE;ORAL | Prescription | AB | No | No |
OXAZEPAM | OXAZEPAM | 15MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
08/10/1987 | 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-21 | Labeling-Package Insert |
Label is not available on this site. |
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02/05/2021 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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03/17/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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12/16/2016 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/01/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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12/23/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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10/05/1993 | SUPPL-9 | Labeling |
Label is not available on this site. |
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04/03/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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04/03/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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04/19/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
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01/25/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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01/25/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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01/25/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
OXAZEPAM
CAPSULE;ORAL; 30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXAZEPAM | OXAZEPAM | 30MG | CAPSULE;ORAL | Prescription | No | AB | 072253 | ACTAVIS ELIZABETH |
OXAZEPAM | OXAZEPAM | 30MG | CAPSULE;ORAL | Prescription | No | AB | 071814 | EPIC PHARMA LLC |
OXAZEPAM | OXAZEPAM | 30MG | CAPSULE;ORAL | Prescription | No | AB | 071026 | UNITED RES LABS |
CAPSULE;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXAZEPAM | OXAZEPAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 072253 | ACTAVIS ELIZABETH |
OXAZEPAM | OXAZEPAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 071813 | EPIC PHARMA LLC |
OXAZEPAM | OXAZEPAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 071026 | UNITED RES LABS |
CAPSULE;ORAL; 15MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXAZEPAM | OXAZEPAM | 15MG | CAPSULE;ORAL | Prescription | No | AB | 072253 | ACTAVIS ELIZABETH |
OXAZEPAM | OXAZEPAM | 15MG | CAPSULE;ORAL | Prescription | No | AB | 071756 | EPIC PHARMA LLC |
OXAZEPAM | OXAZEPAM | 15MG | CAPSULE;ORAL | Prescription | No | AB | 071026 | UNITED RES LABS |