Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071175
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEMAZEPAM TEMAZEPAM 30MG CAPSULE;ORAL Discontinued None 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
07/10/1986 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
08/12/2019 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

08/12/2019 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/04/2011 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

09/14/2009 SUPPL-16 Labeling

Label is not available on this site.

12/01/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/05/1993 SUPPL-12 Labeling

Label is not available on this site.

04/03/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/01/1991 SUPPL-8 Labeling

Label is not available on this site.

05/31/1990 SUPPL-7 Bioequivalence

Label is not available on this site.

06/07/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/27/1989 SUPPL-4 Labeling

Label is not available on this site.

03/31/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

TEMAZEPAM

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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