Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071457
Company: NOVEL LABS INC
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 7.5MG CAPSULE;ORAL Prescription AB No No
TEMAZEPAM TEMAZEPAM 22.5MG 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
04/21/1987 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
08/27/2019 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

06/22/2012 SUPPL-11 Manufacturing (CMC)-New Strength

Label is not available on this site.

06/22/2012 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

04/17/2012 SUPPL-9 Labeling

Label is not available on this site.

07/07/2004 SUPPL-6 Labeling

Label is not available on this site.

12/28/1993 SUPPL-5 Labeling

Label is not available on this site.

02/04/1991 SUPPL-4 Labeling

Label is not available on this site.

06/12/1989 SUPPL-3 Labeling

Label is not available on this site.

11/04/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/31/1989 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

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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