Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211542
Company: ALEMBIC
Company: ALEMBIC
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 |
---|---|---|---|---|---|---|---|
11/23/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/30/2023 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
06/11/2021 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
06/11/2021 | SUPPL-1 | Labeling-Container/Carton Labels, 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 |