Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017422
Company: AVET LIFESCIENCES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BICNU CARMUSTINE 100MG/VIAL 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
03/07/1977 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
03/24/2017 SUPPL-55 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017422s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017422Orig1s055ltr.pdf
04/28/2016 SUPPL-50 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017422Orig2s050Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017422Orig1s050ltr.pdf
11/25/2015 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

06/13/2014 SUPPL-47 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/017422Orig1s047.pdf
10/18/2013 SUPPL-46 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017422s046lbl.pdf
09/18/2013 SUPPL-45 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/017422Orig1s045.pdf
08/11/2011 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017422s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017422s042ltr.pdf
03/14/2011 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017422s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017422s038ltr.pdf
08/17/2007 SUPPL-37 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017422s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017422s037ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/017422Orig1s037.pdf
10/20/2005 SUPPL-36 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017422s036ltr.pdf
02/27/2003 SUPPL-35 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17422slr035ltr.pdf
09/10/1997 SUPPL-34 Labeling

Label is not available on this site.

07/13/1992 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/1992 SUPPL-31 Labeling

Label is not available on this site.

06/13/1991 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

01/03/1991 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/14/1989 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/1989 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/17/1988 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1988 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1987 SUPPL-22 Labeling

Label is not available on this site.

08/07/1987 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

03/05/1987 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/19/1986 SUPPL-18 Labeling

Label is not available on this site.

05/19/1986 SUPPL-17 Labeling

Label is not available on this site.

05/19/1986 SUPPL-16 Labeling

Label is not available on this site.

07/11/1986 SUPPL-15 Labeling

Label is not available on this site.

12/10/1984 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1984 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/1984 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1983 SUPPL-11 Labeling

Label is not available on this site.

02/17/1984 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/10/1983 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/21/1987 SUPPL-8 Labeling

Label is not available on this site.

02/16/1982 SUPPL-7 Labeling

Label is not available on this site.

04/03/1984 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/12/1980 SUPPL-5 Labeling

Label is not available on this site.

10/09/1979 SUPPL-4 Labeling

Label is not available on this site.

10/09/1979 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/15/1978 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/22/1977 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
03/24/2017 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017422s055lbl.pdf
04/28/2016 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017422Orig2s050Lbl.pdf
10/18/2013 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017422s046lbl.pdf
08/11/2011 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017422s042lbl.pdf
03/14/2011 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017422s038lbl.pdf
08/17/2007 SUPPL-37 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017422s037lbl.pdf
08/17/2007 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017422s037lbl.pdf

BICNU

INJECTABLE;INJECTION; 100MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BICNU CARMUSTINE 100MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 017422 AVET LIFESCIENCES
CARMUSTINE CARMUSTINE 100MG/VIAL INJECTABLE;INJECTION Prescription No AP 211229 AMNEAL
CARMUSTINE CARMUSTINE 100MG/VIAL INJECTABLE;INJECTION Prescription No AP 213207 DR REDDYS
CARMUSTINE CARMUSTINE 100MG/VIAL INJECTABLE;INJECTION Prescription No AP 211202 JIANGSU PHARMS
CARMUSTINE CARMUSTINE 100MG/VIAL INJECTABLE;INJECTION Prescription No AP 213460 MEITHEAL
CARMUSTINE CARMUSTINE 100MG/VIAL INJECTABLE;INJECTION Prescription No AP 210179 NAVINTA LLC
CARMUSTINE CARMUSTINE 100MG/VIAL INJECTABLE;INJECTION Prescription No AP 209278 STI PHARMA LLC

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