Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071456
Company: NOVEL LABS INC
Company: NOVEL LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 03/14/2024 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/20/2019 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/17/2012 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 12/14/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/28/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/04/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/12/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/04/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
TEMAZEPAM
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 |