Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018140
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATIVAN LORAZEPAM 2MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
ATIVAN LORAZEPAM 4MG/ML INJECTABLE;INJECTION Prescription AP 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
07/25/1980 ORIG-1 Approval Type 3 - New Dosage Form 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
04/27/2017 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018140s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018140Orig1s041,018140Oirg1s042ltr.pdf
04/27/2017 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018140s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018140Orig1s041,018140Oirg1s042ltr.pdf
05/27/2016 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018140s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018140Orig1s040ltr.pdf
10/02/2015 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

04/18/2016 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

11/29/2006 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018140s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018140s028ltr.pdf
12/12/2001 SUPPL-27 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018140_S027_ATIVAN_INJECTION_AP.pdf
09/26/2000 SUPPL-26 Labeling

Label is not available on this site.

11/04/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/16/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/26/1996 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/19/1996 SUPPL-22 Labeling

Label is not available on this site.

03/08/1995 SUPPL-21 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/06/1995 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

09/29/1993 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/29/1993 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/03/1993 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1992 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/26/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/02/1991 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/03/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/19/1996 SUPPL-12 Labeling

Label is not available on this site.

03/19/1996 SUPPL-11 Labeling

Label is not available on this site.

06/13/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/19/1996 SUPPL-9 Labeling

Label is not available on this site.

04/13/1987 SUPPL-8 Labeling

Label is not available on this site.

04/24/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/14/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/14/1984 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/1983 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/05/1997 SUPPL-3 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018140ap_s003.pdf
02/02/1981 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/09/1980 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/27/2017 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018140s041s042lbl.pdf
04/27/2017 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018140s041s042lbl.pdf
05/27/2016 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018140s040lbl.pdf
11/29/2006 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018140s028lbl.pdf

ATIVAN

INJECTABLE;INJECTION; 2MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATIVAN LORAZEPAM 2MG/ML INJECTABLE;INJECTION Prescription Yes AP 018140 WEST-WARD PHARMS INT
LORAZEPAM LORAZEPAM 2MG/ML INJECTABLE;INJECTION Prescription No AP 075025 AKORN
LORAZEPAM LORAZEPAM 2MG/ML INJECTABLE;INJECTION Prescription No AP 074243 HOSPIRA
LORAZEPAM LORAZEPAM 2MG/ML INJECTABLE;INJECTION Prescription No AP 074282 HOSPIRA
LORAZEPAM LORAZEPAM 2MG/ML INJECTABLE;INJECTION Prescription No AP 076150 INTL MEDICATION SYS
LORAZEPAM LORAZEPAM 2MG/ML INJECTABLE;INJECTION Prescription No AP 200217 SAGENT AGILA LLC
LORAZEPAM LORAZEPAM 2MG/ML INJECTABLE;INJECTION Prescription No AP 200542 SAGENT AGILA LLC
LORAZEPAM PRESERVATIVE FREE LORAZEPAM 2MG/ML INJECTABLE;INJECTION Prescription No AP 077074 BEDFORD LABS

INJECTABLE;INJECTION; 4MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATIVAN LORAZEPAM 4MG/ML INJECTABLE;INJECTION Prescription Yes AP 018140 WEST-WARD PHARMS INT
LORAZEPAM LORAZEPAM 4MG/ML INJECTABLE;INJECTION Prescription No AP 074243 HOSPIRA
LORAZEPAM LORAZEPAM 4MG/ML INJECTABLE;INJECTION Prescription No AP 074282 HOSPIRA
LORAZEPAM LORAZEPAM 4MG/ML INJECTABLE;INJECTION Prescription No AP 200217 SAGENT AGILA LLC
LORAZEPAM LORAZEPAM 4MG/ML INJECTABLE;INJECTION Prescription No AP 200542 SAGENT AGILA LLC
LORAZEPAM PRESERVATIVE FREE LORAZEPAM 4MG/ML INJECTABLE;INJECTION Prescription No AP 077074 BEDFORD LABS

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