Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021995
Company: MERCK SHARP DOHME
Company: MERCK SHARP DOHME
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| JANUVIA | SITAGLIPTIN PHOSPHATE | EQ 25MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| JANUVIA | SITAGLIPTIN PHOSPHATE | EQ 50MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| JANUVIA | SITAGLIPTIN PHOSPHATE | EQ 100MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 10/16/2006 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021995lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021995s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021995s000TOC.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/28/2023 | SUPPL-53 | Manufacturing (CMC)-Facility |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021995Orig1s053lbl.pdf | |
| 06/21/2022 | SUPPL-50 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021995s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021995Orig1s050, 022044Orig1s052, 202270Orig1s026ltr.pdf | |
| 12/04/2020 | SUPPL-47 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021995s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021995Orig1s047; 022044Orig1s048; 202270Orig1s022ltr.pdf | |
| 07/01/2019 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021995s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021995Orig1s046, 022044Orig1s047, 202270Orig1s020ltr.pdf | |
| 08/12/2019 | SUPPL-45 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021995s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021995Orig1s045, 202270Orig1s019, 022044Orig1s046.ltr.pdf | |
| 02/09/2018 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021995s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021995Orig1s042,022044s043,202270Orig1s018ltr.pdf | |
| 08/10/2017 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021995s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021995Orig1s040,022044Orig1s042,202270Orig1s017ltr.pdf | |
| 01/18/2017 | SUPPL-38 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021995s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021995Orig1s038ltr.pdf | |
| 01/11/2016 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/2015 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s034,022044Orig1s035,202270Orig1s010ltr.pdf | |
| 04/27/2015 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s033,022044Orig1s034,202270Orig1s009ltr.pdf | |
| 03/10/2015 | SUPPL-32 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s032ltr.pdf | |
| 08/19/2013 | SUPPL-29 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021995Orig1s029ltr.pdf | |
| 10/17/2013 | SUPPL-28 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s028lbl.pdf | |
| 02/11/2013 | SUPPL-27 | Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021995Orig1s027ltr_replacement.pdf | |
| 12/07/2012 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/2012 | SUPPL-25 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021995Orig1s025ltr.pdf | |
| 03/24/2012 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021995s023ltr.pdf | |
| 02/27/2012 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s019lbl.pdf | |
| 09/24/2010 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s015s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s015,s018ltr.pdf | |
| 04/14/2011 | SUPPL-17 | REMS-Modified, Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021995s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021995s017ltr.pdf | |
| 06/10/2011 | SUPPL-16 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf |
| 09/24/2010 | SUPPL-15 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s015s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s015,s018ltr.pdf | |
| 02/26/2010 | SUPPL-14 | Labeling-Medication Guide, REMS-Proposal |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021995Orig1s014.pdf | |
| 12/28/2009 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021995s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021995s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021995Orig1s013.pdf | |
| 02/26/2010 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf | |
| 02/26/2010 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf | |
| 02/26/2010 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf | |
| 10/20/2008 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021995s009ltr.pdf |
| 07/22/2008 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021995s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021995s007ltr.pdf | |
| 10/12/2007 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf |
| 10/12/2007 | SUPPL-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf |
| 10/12/2007 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf |
| 10/12/2007 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf |
| 04/10/2007 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/28/2023 | SUPPL-53 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021995Orig1s053lbl.pdf | |
| 06/21/2022 | SUPPL-50 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021995s050lbl.pdf | |
| 06/21/2022 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021995s050lbl.pdf | |
| 12/04/2020 | SUPPL-47 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021995s047lbl.pdf | |
| 08/12/2019 | SUPPL-45 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021995s045lbl.pdf | |
| 07/01/2019 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021995s046lbl.pdf | |
| 02/09/2018 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021995s042lbl.pdf | |
| 08/10/2017 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021995s040lbl.pdf | |
| 01/18/2017 | SUPPL-38 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021995s038lbl.pdf | |
| 08/28/2015 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s034lbl.pdf | |
| 04/27/2015 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s033lbl.pdf | |
| 03/10/2015 | SUPPL-32 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s032lbl.pdf |
| 10/17/2013 | SUPPL-28 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s028lbl.pdf |
| 08/19/2013 | SUPPL-29 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s029lbl.pdf | |
| 02/11/2013 | SUPPL-27 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s027lbl.pdf | |
| 02/11/2013 | SUPPL-27 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s027lbl.pdf | |
| 10/18/2012 | SUPPL-25 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s025lbl.pdf | |
| 03/24/2012 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s023lbl.pdf | |
| 02/27/2012 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s019lbl.pdf | |
| 04/14/2011 | SUPPL-17 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021995s017lbl.pdf | |
| 04/14/2011 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021995s017lbl.pdf | |
| 09/24/2010 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s015s018lbl.pdf | |
| 09/24/2010 | SUPPL-15 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s015s018lbl.pdf | |
| 02/26/2010 | SUPPL-14 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf | |
| 02/26/2010 | SUPPL-14 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf | |
| 02/26/2010 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf | |
| 02/26/2010 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf | |
| 02/26/2010 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf | |
| 12/28/2009 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021995s013lbl.pdf | |
| 07/22/2008 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021995s007lbl.pdf | |
| 10/16/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021995lbl.pdf |
JANUVIA
TABLET;ORAL; EQ 25MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JANUVIA | SITAGLIPTIN PHOSPHATE | EQ 25MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021995 | MERCK SHARP DOHME |
| SITAGLIPTIN PHOSPHATE | SITAGLIPTIN PHOSPHATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 202425 | APOTEX |
| SITAGLIPTIN PHOSPHATE | SITAGLIPTIN PHOSPHATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 202387 | SANDOZ |
| SITAGLIPTIN PHOSPHATE | SITAGLIPTIN PHOSPHATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 202327 | WATSON LABS INC |
TABLET;ORAL; EQ 50MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JANUVIA | SITAGLIPTIN PHOSPHATE | EQ 50MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021995 | MERCK SHARP DOHME |
| SITAGLIPTIN PHOSPHATE | SITAGLIPTIN PHOSPHATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 202425 | APOTEX |
| SITAGLIPTIN PHOSPHATE | SITAGLIPTIN PHOSPHATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 202387 | SANDOZ |
| SITAGLIPTIN PHOSPHATE | SITAGLIPTIN PHOSPHATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 202327 | WATSON LABS INC |
TABLET;ORAL; EQ 100MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JANUVIA | SITAGLIPTIN PHOSPHATE | EQ 100MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021995 | MERCK SHARP DOHME |
| SITAGLIPTIN PHOSPHATE | SITAGLIPTIN PHOSPHATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 202425 | APOTEX |
| SITAGLIPTIN PHOSPHATE | SITAGLIPTIN PHOSPHATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 202387 | SANDOZ |
| SITAGLIPTIN PHOSPHATE | SITAGLIPTIN PHOSPHATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 202327 | WATSON LABS INC |