Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071428
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEMAZEPAM TEMAZEPAM 30MG 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
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-Container/Carton Labels, 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.

09/10/1991 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; 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

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