Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017422
Company: AVET LIFESCIENCES
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 |
|---|---|---|---|---|---|
| 04/30/2021 | SUPPL-62 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017422Orig1s062ltr.pdf |
| 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-Package Insert, Labeling-Container/Carton Labels |
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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017422s037lbl.pdf | |
| 08/17/2007 | SUPPL-37 | Labeling-Container/Carton Labels | 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 | 215730 | ALEMBIC |
| 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 | HENGRUI PHARMA |
| CARMUSTINE | CARMUSTINE | 100MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 213460 | MEITHEAL |
| CARMUSTINE | CARMUSTINE | 100MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 214814 | MSN |
| CARMUSTINE | CARMUSTINE | 100MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 210179 | NAVINTA LLC |
| CARMUSTINE | CARMUSTINE | 100MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 209278 | PENN LIFE |