Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018163
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
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-Package Insert, Labeling-Medication Guide 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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018163s064lbl.pdf
12/16/2016 SUPPL-64 Labeling-Medication Guide 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 PHARMS LTD
TEMAZEPAM TEMAZEPAM 15MG CAPSULE;ORAL Prescription No AB 203482 AMNEAL PHARMS
TEMAZEPAM TEMAZEPAM 15MG CAPSULE;ORAL Prescription No AB 070920 MYLAN
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 PHARMS LTD
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;ORAL Prescription No AB 203482 AMNEAL PHARMS
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;ORAL Prescription No AB 070920 MYLAN
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 PHARMS LTD
TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription No AB 203482 AMNEAL PHARMS
TEMAZEPAM TEMAZEPAM 7.5MG CAPSULE;ORAL Prescription No AB 070920 MYLAN
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 PHARMS LTD
TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE;ORAL Prescription No AB 203482 AMNEAL PHARMS
TEMAZEPAM TEMAZEPAM 22.5MG CAPSULE;ORAL Prescription No AB 070920 MYLAN
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

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