Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070920
Company: MYLAN
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
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
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
08/26/2019 SUPPL-32 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/26/2019 SUPPL-30 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/04/2016 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

05/21/2010 SUPPL-24 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/070920Orig1s024Approv.pdf
05/21/2010 SUPPL-23 Efficacy-New Dosing Regimen Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/070920Orig1s023Approv.pdf
06/12/2009 SUPPL-20 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/070920Orig1s020Approv.pdf
06/12/2009 SUPPL-19 Efficacy-New Dosing Regimen Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/070920Orig1s019Approv.pdf
09/25/2003 SUPPL-13 Labeling

Label is not available on this site.

11/07/2001 SUPPL-12 Labeling

Label is not available on this site.

03/01/2001 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/09/1998 SUPPL-10 Labeling

Label is not available on this site.

02/05/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/06/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/01/1993 SUPPL-6 Labeling

Label is not available on this site.

02/19/1991 SUPPL-5 Labeling

Label is not available on this site.

01/31/1990 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/19/1988 SUPPL-3 Labeling

Label is not available on this site.

05/10/1988 SUPPL-2 Labeling

Label is not available on this site.

09/19/1986 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

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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