Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 019938
Company: NOVO NORDISK INC
Company: NOVO NORDISK INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NOVOLIN R | INSULIN RECOMBINANT HUMAN | 100 UNITS/ML | INJECTABLE;INJECTION | Over-the-counter | None | 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 |
|---|---|---|---|---|---|---|---|
| 06/25/1991 | ORIG-1 | Approval | N/A |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/23/2022 | SUPPL-82 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019938s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019938Orig1s082ltr.pdf | |
| 11/15/2019 | SUPPL-79 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019938s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019991Orig1s082; 019959Orig1s082; 019938Orig1s079ltr.pdf | |
| 06/01/2018 | SUPPL-76 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019938s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019938Orig1s076ltr.pdf | |
| 11/18/2016 | SUPPL-75 | Supplement |
Label is not available on this site. |
||
| 01/08/2016 | SUPPL-74 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019938s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019938Orig1s074ltr.pdf | |
| 12/01/2015 | SUPPL-73 | Supplement |
Label is not available on this site. |
||
| 02/07/2013 | SUPPL-72 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019938s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019938Orig1s072ltr.pdf | |
| 03/09/2013 | SUPPL-71 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019938s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s068_019959s070_019991s071ltr.pdf | |
| 06/25/2010 | SUPPL-69 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf |
| 12/27/2010 | SUPPL-68 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s068_019959s070_019991s071ltr.pdf |
| 06/25/2010 | SUPPL-67 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf |
| 02/27/2012 | SUPPL-66 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019938s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019938s066ltr.pdf | |
| 07/17/2009 | SUPPL-64 | Supplement |
Label (PDF)
Letter |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s064,019959s067,019991s068,020986s055ltr.pd | |
| 06/15/2009 | SUPPL-63 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s063,019959s066,019991s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s063,019959s066,019991s067ltr.pdf | |
| 10/21/2005 | SUPPL-48 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019938s048lbl.pdf | |
| 11/18/2005 | SUPPL-37 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019938s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019938s037ltr.pdf | |
| 06/19/2002 | SUPPL-36 | Supplement |
Label is not available on this site. |
||
| 01/10/2002 | SUPPL-35 | Supplement |
Label is not available on this site. |
||
| 12/19/2001 | SUPPL-34 | Supplement |
Label is not available on this site. |
||
| 04/15/2002 | SUPPL-33 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s33lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19938s33ltr.pdf | |
| 04/11/2002 | SUPPL-32 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s32lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19959s34ltr.pdf | |
| 01/09/2001 | SUPPL-31 | Supplement |
Label is not available on this site. |
||
| 03/11/2002 | SUPPL-30 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19-938S30lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19938s30ltr.pdf | |
| 12/10/2001 | SUPPL-29 | Supplement |
Label is not available on this site. |
||
| 06/15/2000 | SUPPL-27 | Supplement |
Label is not available on this site. |
||
| 04/10/2000 | SUPPL-26 | Supplement |
Label is not available on this site. |
||
| 03/16/2000 | SUPPL-25 | Supplement |
Label is not available on this site. |
||
| 10/18/1999 | SUPPL-24 | Supplement |
Label is not available on this site. |
||
| 07/24/1998 | SUPPL-23 | Supplement |
Label is not available on this site. |
||
| 08/04/1997 | SUPPL-22 | Supplement |
Label is not available on this site. |
||
| 06/20/1997 | SUPPL-21 | Supplement |
Label is not available on this site. |
||
| 04/16/1997 | SUPPL-20 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019938ap.pdf |
| 04/10/1997 | SUPPL-19 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019938a_s019.pdf |
| 06/13/1996 | SUPPL-18 | Supplement |
Label is not available on this site. |
||
| 01/28/1997 | SUPPL-17 | Supplement |
Label is not available on this site. |
||
| 08/16/1995 | SUPPL-16 | Supplement |
Label is not available on this site. |
||
| 05/22/1995 | SUPPL-15 | Supplement |
Label is not available on this site. |
||
| 01/04/1994 | SUPPL-14 | Supplement |
Label is not available on this site. |
||
| 01/03/1994 | SUPPL-13 | Supplement |
Label is not available on this site. |
||
| 06/23/1994 | SUPPL-12 | Supplement |
Label is not available on this site. |
||
| 06/23/1994 | SUPPL-11 | Supplement |
Label is not available on this site. |
||
| 06/16/1994 | SUPPL-10 | Supplement |
Label is not available on this site. |
||
| 05/31/1994 | SUPPL-9 | Supplement |
Label is not available on this site. |
||
| 05/23/1994 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
| 04/26/1994 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
| 01/07/1994 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
| 03/26/1993 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
| 03/26/1993 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
| 03/13/1992 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
| 10/07/1991 | SUPPL-1 | Supplement |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/23/2022 | SUPPL-82 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019938s082lbl.pdf | |
| 11/23/2022 | SUPPL-82 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019938s082lbl.pdf | |
| 11/23/2022 | SUPPL-82 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019938s082lbl.pdf | |
| 11/15/2019 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019938s079lbl.pdf | |
| 11/15/2019 | SUPPL-79 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019938s079lbl.pdf | |
| 06/01/2018 | SUPPL-76 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019938s076lbl.pdf | |
| 01/08/2016 | SUPPL-74 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019938s074lbl.pdf | |
| 03/09/2013 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019938s071lbl.pdf | |
| 03/09/2013 | SUPPL-71 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019938s071lbl.pdf | |
| 02/07/2013 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019938s072lbl.pdf | |
| 02/27/2012 | SUPPL-66 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019938s066lbl.pdf | |
| 07/17/2009 | SUPPL-64 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf | |
| 07/17/2009 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf | |
| 06/15/2009 | SUPPL-63 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s063,019959s066,019991s067lbl.pdf | |
| 11/18/2005 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019938s037lbl.pdf | |
| 10/21/2005 | SUPPL-48 | Efficacy-New Route Of Administration | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019938s048lbl.pdf | |
| 04/15/2002 | SUPPL-33 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s33lbl.pdf | |
| 04/11/2002 | SUPPL-32 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s32lbl.pdf | |
| 03/11/2002 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19-938S30lbl.pdf |
NOVOLIN R
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
INJECTABLE;INJECTION; 100 UNITS/ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| HUMULIN R | INSULIN RECOMBINANT HUMAN | 100 UNITS/ML | INJECTABLE;INJECTION | Over-the-counter | No | 018780 | LILLY |
| HUMULIN R PEN | INSULIN RECOMBINANT HUMAN | 100 UNITS/ML | INJECTABLE;INJECTION | Over-the-counter | No | 018780 | LILLY |
| NOVOLIN R | INSULIN RECOMBINANT HUMAN | 100 UNITS/ML | INJECTABLE;INJECTION | Over-the-counter | No | 019938 | NOVO NORDISK INC |