Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017794
Company: VALEANT INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATIVAN LORAZEPAM 0.5MG TABLET;ORAL Prescription AB Yes No
ATIVAN LORAZEPAM 1MG TABLET;ORAL Prescription AB Yes No
ATIVAN LORAZEPAM 2MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/30/1977 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/16/2016 SUPPL-44 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017794s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017794Orig1s044ltr.pdf
04/18/2007 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017794s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017794s035_LTR.pdf
04/20/1988 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/04/1987 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1987 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1987 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/1987 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/29/1986 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/30/1986 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

12/15/1986 SUPPL-22 Labeling

Label is not available on this site.

12/26/1984 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1985 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/02/1984 SUPPL-18 Labeling

Label is not available on this site.

02/24/1984 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/29/1983 SUPPL-16 Labeling

Label is not available on this site.

09/29/1983 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1982 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/10/1982 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/1982 SUPPL-10 Labeling

Label is not available on this site.

05/03/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/18/1980 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1980 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/02/1980 SUPPL-6 Labeling

Label is not available on this site.

09/02/1980 SUPPL-5 Labeling

Label is not available on this site.

01/24/1979 SUPPL-4 Labeling

Label is not available on this site.

09/20/1978 SUPPL-3 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/16/2016 SUPPL-44 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017794s044lbl.pdf
12/16/2016 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017794s044lbl.pdf
04/18/2007 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017794s034s035lbl.pdf

ATIVAN

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATIVAN LORAZEPAM 0.5MG TABLET;ORAL Prescription Yes AB 017794 VALEANT INTL
LORAZEPAM LORAZEPAM 0.5MG TABLET;ORAL Prescription No AB 078826 AMNEAL PHARMS
LORAZEPAM LORAZEPAM 0.5MG TABLET;ORAL Prescription No AB 077396 ANI PHARMS INC
LORAZEPAM LORAZEPAM 0.5MG TABLET;ORAL Prescription No AB 078203 LEADING PHARMA LLC
LORAZEPAM LORAZEPAM 0.5MG TABLET;ORAL Prescription No AB 071589 MYLAN
LORAZEPAM LORAZEPAM 0.5MG TABLET;ORAL Prescription No AB 077657 MYLAN
LORAZEPAM LORAZEPAM 0.5MG TABLET;ORAL Prescription No AB 076045 SUN PHARM INDS LTD
LORAZEPAM LORAZEPAM 0.5MG TABLET;ORAL Prescription No AB 077754 VINTAGE PHARMS
LORAZEPAM LORAZEPAM 0.5MG TABLET;ORAL Prescription No AB 072926 WATSON LABS

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATIVAN LORAZEPAM 1MG TABLET;ORAL Prescription Yes AB 017794 VALEANT INTL
LORAZEPAM LORAZEPAM 1MG TABLET;ORAL Prescription No AB 078826 AMNEAL PHARMS
LORAZEPAM LORAZEPAM 1MG TABLET;ORAL Prescription No AB 077396 ANI PHARMS INC
LORAZEPAM LORAZEPAM 1MG TABLET;ORAL Prescription No AB 078203 LEADING PHARMA LLC
LORAZEPAM LORAZEPAM 1MG TABLET;ORAL Prescription No AB 071590 MYLAN
LORAZEPAM LORAZEPAM 1MG TABLET;ORAL Prescription No AB 077657 MYLAN
LORAZEPAM LORAZEPAM 1MG TABLET;ORAL Prescription No AB 071141 SANDOZ
LORAZEPAM LORAZEPAM 1MG TABLET;ORAL Prescription No AB 071404 SANDOZ
LORAZEPAM LORAZEPAM 1MG TABLET;ORAL Prescription No AB 076045 SUN PHARM INDS LTD
LORAZEPAM LORAZEPAM 1MG TABLET;ORAL Prescription No AB 077754 VINTAGE PHARMS
LORAZEPAM LORAZEPAM 1MG TABLET;ORAL Prescription No AB 072927 WATSON LABS

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATIVAN LORAZEPAM 2MG TABLET;ORAL Prescription Yes AB 017794 VALEANT INTL
LORAZEPAM LORAZEPAM 2MG TABLET;ORAL Prescription No AB 078826 AMNEAL PHARMS
LORAZEPAM LORAZEPAM 2MG TABLET;ORAL Prescription No AB 077396 ANI PHARMS INC
LORAZEPAM LORAZEPAM 2MG TABLET;ORAL Prescription No AB 078203 LEADING PHARMA LLC
LORAZEPAM LORAZEPAM 2MG TABLET;ORAL Prescription No AB 071591 MYLAN
LORAZEPAM LORAZEPAM 2MG TABLET;ORAL Prescription No AB 077657 MYLAN
LORAZEPAM LORAZEPAM 2MG TABLET;ORAL Prescription No AB 071141 SANDOZ
LORAZEPAM LORAZEPAM 2MG TABLET;ORAL Prescription No AB 076045 SUN PHARM INDS LTD
LORAZEPAM LORAZEPAM 2MG TABLET;ORAL Prescription No AB 077754 VINTAGE PHARMS
LORAZEPAM LORAZEPAM 2MG TABLET;ORAL Prescription No AB 072928 WATSON LABS

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