Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203482
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TEMAZEPAM | TEMAZEPAM | 7.5MG | CAPSULE;ORAL | Prescription | AB | No | No |
TEMAZEPAM | TEMAZEPAM | 15MG | CAPSULE;ORAL | Prescription | AB | No | No |
TEMAZEPAM | TEMAZEPAM | 22.5MG | CAPSULE;ORAL | Prescription | AB | No | No |
TEMAZEPAM | TEMAZEPAM | 30MG | 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 |
---|---|---|---|---|---|---|---|
05/23/2016 | 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 |
---|---|---|---|---|---|
11/17/2023 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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01/11/2023 | SUPPL-12 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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01/11/2023 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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01/11/2023 | SUPPL-3 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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01/11/2023 | SUPPL-1 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
TEMAZEPAM
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; 15MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RESTORIL | TEMAZEPAM | 15MG | CAPSULE;ORAL | Prescription | Yes | AB | 018163 | SPECGX LLC |
TEMAZEPAM | TEMAZEPAM | 15MG | CAPSULE;ORAL | Prescription | No | AB | 071620 | ACTAVIS ELIZABETH |
TEMAZEPAM | TEMAZEPAM | 15MG | CAPSULE;ORAL | Prescription | No | AB | 211542 | ALEMBIC |
TEMAZEPAM | TEMAZEPAM | 15MG | CAPSULE;ORAL | Prescription | No | AB | 217875 | ALKEM LABS LTD |
TEMAZEPAM | TEMAZEPAM | 15MG | CAPSULE;ORAL | Prescription | No | AB | 203482 | AMNEAL PHARMS |
TEMAZEPAM | TEMAZEPAM | 15MG | CAPSULE;ORAL | Prescription | No | AB | 071427 | CHARTWELL RX |
TEMAZEPAM | TEMAZEPAM | 15MG | CAPSULE;ORAL | Prescription | No | AB | 071456 | NOVEL LABS INC |
TEMAZEPAM | TEMAZEPAM | 15MG | CAPSULE;ORAL | Prescription | No | AB | 201781 | PRINSTON INC |
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 |
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 |