Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071427
Company: CHARTWELL RX
Company: CHARTWELL RX
| 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 |
|---|---|---|---|---|---|---|---|
| 01/12/1988 | 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 |
|---|---|---|---|---|---|
| 06/21/2023 | SUPPL-34 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/21/2021 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/06/2019 | SUPPL-31 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/06/2019 | SUPPL-30 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/03/2011 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/08/2008 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 11/06/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/01/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/09/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/22/1989 | 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 |