Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071620
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;ORAL Prescription AB No No
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
08/07/1987 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
09/30/2019 SUPPL-38 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/30/2019 SUPPL-37 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/31/2009 SUPPL-28 Labeling

Label is not available on this site.

12/12/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/2001 SUPPL-13 Labeling

Label is not available on this site.

01/18/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/09/1993 SUPPL-11 Labeling

Label is not available on this site.

12/28/1992 SUPPL-10 Labeling

Label is not available on this site.

10/21/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/21/1990 SUPPL-8 Bioequivalence

Label is not available on this site.

09/25/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/07/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/20/1988 SUPPL-2 Labeling

Label is not available on this site.

10/05/1987 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

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

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