Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021428
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREVACID | LANSOPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | AB | Yes | No |
| PREVACID | LANSOPRAZOLE | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED 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 |
|---|---|---|---|---|---|---|---|
| 08/30/2002 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21428,20406s052,21281s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21428_20406s052_21281s007_PrevacidTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/08/2023 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020406s095,021428s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020406Orig1s095;021428Orig1s042ltr.pdf | |
| 03/04/2022 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020406s094,021428s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020406Orig1s094; 021428Orig1s041ltr.pdf | |
| 11/27/2020 | SUPPL-39 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020406s092,021428s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020406Orig1s092;021428Orig1s039ltr.pdf | |
| 09/11/2020 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020406s090,021428s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020406Orig1s090, 021428Orig1s037ltr.pdf | |
| 06/07/2018 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020406Orig1s087, s088, 021428Orig1s034, s035ltr.pdf | |
| 06/07/2018 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020406Orig1s087, s088, 021428Orig1s034, s035ltr.pdf | |
| 04/13/2018 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s084,021428s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020406Orig1s084,021428Orig1s032ltr.pdf | |
| 10/18/2017 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020406s083,021428s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020406Orig1s083,021428Orig1s031ltr.pdf | |
| 10/24/2016 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020406s082,021428s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021428Orig1s030,020406Orig1s082ltr.pdf | |
| 12/19/2014 | SUPPL-28 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020406Orig1s081,021428Orig1s028ltr.pdf | |
| 12/16/2015 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020406s080-021428s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020406Orig1s080;021428Orig1s027ltr.pdf | |
| 05/03/2012 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s079,021428s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020406s079,021428s026ltr.pdf | |
| 09/28/2012 | SUPPL-25 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s078-021428s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020406Orig1s078,021428Orig1s025ltr.pdf | |
| 05/20/2011 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s077,021428s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s077,021428s024ltr.pdf | |
| 10/28/2011 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s076,021428s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s076,021428s023ltr.pdf | |
| 06/01/2011 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s075,021428s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s075,021428s022ltr.pdf | |
| 09/03/2010 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s074,021428s021lbl.pdf | |
| 05/12/2010 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s073,021428s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020406s073,021428s020ltr.pdf | |
| 07/31/2009 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020406s071,021281s026,021428s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020406s071,021281s026,021428s019ltr.pdf | |
| 10/28/2008 | SUPPL-17 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020406s067,021281s024,021428s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020406s067, 021281s024, 021428s017ltr.pdf | |
| 04/21/2008 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021281s022, 020406s065, 021428s013ltr.pdf |
| 06/14/2007 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020406s064,021281s021,021428s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020406s064, 021281s021, 021428s012ltr.pdf | |
| 04/12/2006 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020406s058,021281s017,021428s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020406s058, 021281s017, 021428s006ltr.pdf | |
| 06/17/2004 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020406s057_021281s014_021428s004lbl%20.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20406se5-057,21281se8-014,21428se8-004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021428_S004_PREVACID DELAYED RELEASE CAPS.pdf | |
| 06/15/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/05/2003 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21428slr001,21281slr009,20406slr055ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/08/2023 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020406s095,021428s042lbl.pdf | |
| 03/04/2022 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020406s094,021428s041lbl.pdf | |
| 11/27/2020 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020406s092,021428s039lbl.pdf | |
| 11/27/2020 | SUPPL-39 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020406s092,021428s039lbl.pdf | |
| 09/11/2020 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020406s090,021428s037lbl.pdf | |
| 06/07/2018 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf | |
| 06/07/2018 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf | |
| 04/13/2018 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s084,021428s032lbl.pdf | |
| 10/18/2017 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020406s083,021428s031lbl.pdf | |
| 10/24/2016 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020406s082,021428s030lbl.pdf | |
| 12/16/2015 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020406s080-021428s027lbl.pdf | |
| 12/19/2014 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf | |
| 12/19/2014 | SUPPL-28 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf | |
| 09/28/2012 | SUPPL-25 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s078-021428s025lbl.pdf | |
| 05/03/2012 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s079,021428s026lbl.pdf | |
| 10/28/2011 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s076,021428s023lbl.pdf | |
| 06/01/2011 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s075,021428s022lbl.pdf | |
| 05/20/2011 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s077,021428s024lbl.pdf | |
| 09/03/2010 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s074,021428s021lbl.pdf | |
| 05/12/2010 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s073,021428s020lbl.pdf | |
| 07/31/2009 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020406s071,021281s026,021428s019lbl.pdf | |
| 10/28/2008 | SUPPL-17 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020406s067,021281s024,021428s017lbl.pdf | |
| 06/14/2007 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020406s064,021281s021,021428s012lbl.pdf | |
| 04/12/2006 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020406s058,021281s017,021428s006lbl.pdf | |
| 06/17/2004 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020406s057_021281s014_021428s004lbl%20.pdf | |
| 08/30/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf |
PREVACID
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL; 15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LANSOPRAZOLE | LANSOPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 207167 | AUROBINDO PHARMA LTD |
| LANSOPRAZOLE | LANSOPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 210465 | DR REDDYS |
| LANSOPRAZOLE | LANSOPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 202396 | MYLAN |
| LANSOPRAZOLE | LANSOPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 208784 | TEVA PHARMS USA |
| LANSOPRAZOLE | LANSOPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 200816 | ZYDUS PHARMS |
| PREVACID | LANSOPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 021428 | TAKEDA PHARMS USA |
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL; 30MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LANSOPRAZOLE | LANSOPRAZOLE | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 207167 | AUROBINDO PHARMA LTD |
| LANSOPRAZOLE | LANSOPRAZOLE | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 210465 | DR REDDYS |
| LANSOPRAZOLE | LANSOPRAZOLE | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 202396 | MYLAN |
| LANSOPRAZOLE | LANSOPRAZOLE | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 208784 | TEVA PHARMS USA |
| LANSOPRAZOLE | LANSOPRAZOLE | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 200816 | ZYDUS PHARMS |
| PREVACID | LANSOPRAZOLE | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 021428 | TAKEDA PHARMS USA |