Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS ELIZABETH
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 | 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 |
---|---|---|---|---|---|---|---|
08/07/1987 | 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 |
---|---|---|---|---|---|
11/18/2023 | SUPPL-45 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
08/09/2022 | SUPPL-42 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
08/09/2022 | SUPPL-40 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
09/30/2019 | SUPPL-38 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
09/30/2019 | SUPPL-37 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
03/31/2009 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
12/12/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/02/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/01/2001 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
01/18/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/09/1993 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
12/28/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
10/21/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/21/1990 | SUPPL-8 | Bioequivalence |
Label is not available on this site. |
||
09/25/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/07/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/20/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
10/05/1987 | 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; 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 |