Drugs@FDA: FDA-Approved Drugs
Company: NOVEL LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TEMAZEPAM | TEMAZEPAM | 30MG | CAPSULE;ORAL | Prescription | AB | No | No |
TEMAZEPAM | TEMAZEPAM | 7.5MG | CAPSULE;ORAL | Prescription | AB | No | No |
TEMAZEPAM | TEMAZEPAM | 22.5MG | 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 |
---|---|---|---|---|---|---|---|
04/21/1987 | 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 |
---|---|---|---|---|---|
08/03/2022 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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08/27/2019 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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06/22/2012 | SUPPL-11 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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06/22/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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04/17/2012 | SUPPL-9 | Labeling |
Label is not available on this site. |
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07/07/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
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12/28/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
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02/04/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
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06/12/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |
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11/04/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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07/31/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
TEMAZEPAM
CAPSULE;ORAL; 30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RESTORIL | TEMAZEPAM | 30MG | CAPSULE;ORAL | Prescription | Yes | AB | 018163 | SPECGX LLC |
TEMAZEPAM | TEMAZEPAM | 30MG | CAPSULE;ORAL | Prescription | No | AB | 071620 | ACTAVIS ELIZABETH |
TEMAZEPAM | TEMAZEPAM | 30MG | CAPSULE;ORAL | Prescription | No | AB | 211542 | ALEMBIC |
TEMAZEPAM | TEMAZEPAM | 30MG | CAPSULE;ORAL | Prescription | No | AB | 217875 | ALKEM LABS LTD |
TEMAZEPAM | TEMAZEPAM | 30MG | CAPSULE;ORAL | Prescription | No | AB | 203482 | AMNEAL PHARMS |
TEMAZEPAM | TEMAZEPAM | 30MG | CAPSULE;ORAL | Prescription | No | AB | 071428 | CHARTWELL RX |
TEMAZEPAM | TEMAZEPAM | 30MG | CAPSULE;ORAL | Prescription | No | AB | 071457 | NOVEL LABS INC |
TEMAZEPAM | TEMAZEPAM | 30MG | CAPSULE;ORAL | Prescription | No | AB | 201781 | PRINSTON INC |
CAPSULE;ORAL; 7.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RESTORIL | TEMAZEPAM | 7.5MG | CAPSULE;ORAL | Prescription | Yes | AB | 018163 | SPECGX LLC |
TEMAZEPAM | TEMAZEPAM | 7.5MG | CAPSULE;ORAL | Prescription | No | AB | 211542 | ALEMBIC |
TEMAZEPAM | TEMAZEPAM | 7.5MG | CAPSULE;ORAL | Prescription | No | AB | 217875 | ALKEM LABS LTD |
TEMAZEPAM | TEMAZEPAM | 7.5MG | CAPSULE;ORAL | Prescription | No | AB | 203482 | AMNEAL PHARMS |
TEMAZEPAM | TEMAZEPAM | 7.5MG | CAPSULE;ORAL | Prescription | No | AB | 071457 | NOVEL LABS INC |
TEMAZEPAM | TEMAZEPAM | 7.5MG | CAPSULE;ORAL | Prescription | No | AB | 201781 | PRINSTON INC |
TEMAZEPAM | TEMAZEPAM | 7.5MG | CAPSULE;ORAL | Prescription | No | AB | 078581 | SUN PHARM INDUSTRIES |
CAPSULE;ORAL; 22.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RESTORIL | TEMAZEPAM | 22.5MG | CAPSULE;ORAL | Prescription | Yes | AB | 018163 | SPECGX LLC |
TEMAZEPAM | TEMAZEPAM | 22.5MG | CAPSULE;ORAL | Prescription | No | AB | 211542 | ALEMBIC |
TEMAZEPAM | TEMAZEPAM | 22.5MG | CAPSULE;ORAL | Prescription | No | AB | 217875 | ALKEM LABS LTD |
TEMAZEPAM | TEMAZEPAM | 22.5MG | CAPSULE;ORAL | Prescription | No | AB | 203482 | AMNEAL PHARMS |
TEMAZEPAM | TEMAZEPAM | 22.5MG | CAPSULE;ORAL | Prescription | No | AB | 071457 | NOVEL LABS INC |
TEMAZEPAM | TEMAZEPAM | 22.5MG | CAPSULE;ORAL | Prescription | No | AB | 201781 | PRINSTON INC |