Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202270
Company: MSD SUB MERCK
Company: MSD SUB MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| JANUMET XR | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | 500MG;EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| JANUMET XR | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | 1GM;EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| JANUMET XR | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | 1GM;EQ 100MG BASE | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 02/02/2012 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202270s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202270s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202270_janumet_xr_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202270Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/21/2022 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202270s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021995Orig1s050, 022044Orig1s052, 202270Orig1s026ltr.pdf | |
| 11/04/2021 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202270s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202270Orig1s025ltr.pdf | |
| 12/04/2020 | SUPPL-22 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202270Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021995Orig1s047; 022044Orig1s048; 202270Orig1s022ltr.pdf | |
| 07/01/2019 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202270s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021995Orig1s046, 022044Orig1s047, 202270Orig1s020ltr.pdf | |
| 08/12/2019 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202270s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021995Orig1s045, 202270Orig1s019, 022044Orig1s046.ltr.pdf | |
| 02/09/2018 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202270s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021995Orig1s042,022044s043,202270Orig1s018ltr.pdf | |
| 08/10/2017 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021995Orig1s040,022044Orig1s042,202270Orig1s017ltr.pdf | |
| 01/18/2017 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202270Orig1s015,s016ltr.pdf | |
| 01/18/2017 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202270Orig1s015,s016ltr.pdf | |
| 08/28/2015 | SUPPL-10 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202270s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s034,022044Orig1s035,202270Orig1s010ltr.pdf | |
| 04/27/2015 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202270s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s033,022044Orig1s034,202270Orig1s009ltr.pdf | |
| 09/19/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/2014 | SUPPL-6 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202270s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202270Orig1s006ltr.pdf | |
| 10/17/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/19/2013 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/2013 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202270s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202270Orig1s003ltr.pdf | |
| 10/18/2012 | SUPPL-2 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202270s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202270Orig1s002ltr.pdf | |
| 04/10/2013 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/21/2022 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202270s026lbl.pdf | |
| 11/04/2021 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202270s025lbl.pdf | |
| 12/04/2020 | SUPPL-22 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202270Orig1s022lbl.pdf | |
| 08/12/2019 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202270s019lbl.pdf | |
| 07/01/2019 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202270s020lbl.pdf | |
| 02/09/2018 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202270s018lbl.pdf | |
| 08/10/2017 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s017lbl.pdf | |
| 01/18/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s015s016lbl.pdf | |
| 01/18/2017 | SUPPL-16 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s015s016lbl.pdf | |
| 01/18/2017 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s015s016lbl.pdf | |
| 08/28/2015 | SUPPL-10 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202270s010lbl.pdf | |
| 04/27/2015 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202270s009lbl.pdf | |
| 02/12/2014 | SUPPL-6 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202270s006lbl.pdf | |
| 02/11/2013 | SUPPL-3 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202270s003lbl.pdf | |
| 02/11/2013 | SUPPL-3 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202270s003lbl.pdf | |
| 10/18/2012 | SUPPL-2 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202270s002lbl.pdf | |
| 02/02/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202270s000lbl.pdf |
JANUMET XR
TABLET, EXTENDED RELEASE;ORAL; 500MG;EQ 50MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JANUMET XR | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | 500MG;EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 202270 | MSD SUB MERCK |
TABLET, EXTENDED RELEASE;ORAL; 1GM;EQ 50MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JANUMET XR | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | 1GM;EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 202270 | MSD SUB MERCK |
TABLET, EXTENDED RELEASE;ORAL; 1GM;EQ 100MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JANUMET XR | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | 1GM;EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 202270 | MSD SUB MERCK |