Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018163
Company: SPECGX LLC
Company: SPECGX LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RESTORIL | TEMAZEPAM | 15MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| RESTORIL | TEMAZEPAM | 30MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| RESTORIL | TEMAZEPAM | 7.5MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| RESTORIL | TEMAZEPAM | 22.5MG | CAPSULE;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 02/27/1981 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 01/13/2023 | SUPPL-71 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018163s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018163Orig1s071ltr.pdf | |
| 02/05/2021 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018163s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018163Orig1s067ltr.pdf | |
| 02/06/2019 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018163s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018163Orig1s065ltr.pdf | |
| 12/16/2016 | SUPPL-64 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018163s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018163Orig1s064ltr.pdf | |
| 02/25/2008 | SUPPL-59 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018163s058s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018163s058, s059ltr.pdf | |
| 02/25/2008 | SUPPL-58 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018163s058s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018163s058, s059ltr.pdf | |
| 11/02/2004 | SUPPL-57 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18163s057ltr.pdf |
| 11/08/2010 | SUPPL-54 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018163s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018163s054ltr.pdf | |
| 05/31/2002 | SUPPL-53 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18163s053ltr.pdf |
| 10/27/1999 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/1999 | SUPPL-51 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/07/1995 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/18/1995 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/11/2000 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 12/13/1994 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1995 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/15/1993 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/02/1993 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 07/15/1994 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/25/1992 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 07/23/1993 | SUPPL-41 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/10/1992 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 07/13/1994 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/13/1994 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/16/1992 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 04/15/1992 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/17/1994 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/21/1993 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/11/2000 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 03/29/1994 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 02/28/1994 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/19/1994 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 03/14/1990 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/16/1990 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/28/1989 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1990 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 02/16/1990 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/22/1990 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/25/1991 | SUPPL-22 | Efficacy-New Indication |
Label is not available on this site. |
||
| 09/02/1987 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/10/1987 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 04/09/1987 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1986 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/16/1986 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/22/1985 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/22/1985 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/11/1984 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/25/1991 | SUPPL-11 | Efficacy-New Indication |
Label is not available on this site. |
||
| 10/25/1982 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1982 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/26/1981 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1981 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/12/1981 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/13/2023 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018163s071lbl.pdf | |
| 02/05/2021 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018163s067lbl.pdf | |
| 02/06/2019 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018163s065lbl.pdf | |
| 12/16/2016 | SUPPL-64 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018163s064lbl.pdf | |
| 12/16/2016 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018163s064lbl.pdf | |
| 11/08/2010 | SUPPL-54 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018163s054lbl.pdf | |
| 02/25/2008 | SUPPL-59 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018163s058s059lbl.pdf | |
| 02/25/2008 | SUPPL-58 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018163s058s059lbl.pdf |
RESTORIL
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 | 071456 | NOVEL LABS INC |
| TEMAZEPAM | TEMAZEPAM | 15MG | CAPSULE;ORAL | Prescription | No | AB | 201781 | PRINSTON INC |
| TEMAZEPAM | TEMAZEPAM | 15MG | CAPSULE;ORAL | Prescription | No | AB | 071427 | SANDOZ |
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 | 071457 | NOVEL LABS INC |
| TEMAZEPAM | TEMAZEPAM | 30MG | CAPSULE;ORAL | Prescription | No | AB | 201781 | PRINSTON INC |
| TEMAZEPAM | TEMAZEPAM | 30MG | CAPSULE;ORAL | Prescription | No | AB | 071428 | SANDOZ |
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; 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 |
| TEMAZEPAM | TEMAZEPAM | 22.5MG | CAPSULE;ORAL | Prescription | No | AB | 071175 | SUN PHARM INDUSTRIES |