Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021437
Company: UPJOHN
Company: UPJOHN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
INSPRA | EPLERENONE | 25MG | TABLET;ORAL | Prescription | AB | Yes | No |
INSPRA | EPLERENONE | 50MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
INSPRA | EPLERENONE | 100MG | TABLET;ORAL | Discontinued | 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 |
---|---|---|---|---|---|---|---|
09/27/2002 | ORIG-1 | Approval | Type 1 - New Molecular Entity | UNKNOWN |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21437lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21437ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-437_Inspra.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/30/2018 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021437s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021437Orig1s015ltr.pdf | |
05/04/2016 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021437s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021437Orig1s013ltr.pdf | |
07/26/2013 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/16/2013 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021437s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021437Orig1s011ltr.pdf | |
04/15/2013 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/22/2012 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Label (PDF) Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021437s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021437s009_2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021437s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021437Orig1s009ltr.pdf | |
05/07/2008 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021437s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021437s006ltr.pdf | |
01/31/2008 | SUPPL-5 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021437s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021437s005ltr.pdf | |
10/07/2003 | SUPPL-2 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21437se1-002_inspra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21437se1-002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-437s002_Inspra.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/30/2018 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021437s015lbl.pdf | |
05/04/2016 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021437s013lbl.pdf | |
05/16/2013 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021437s011lbl.pdf | |
06/22/2012 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021437s009_2lbl.pdf | |
06/22/2012 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021437s009lbl.pdf | |
05/07/2008 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021437s006lbl.pdf | |
01/31/2008 | SUPPL-5 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021437s005lbl.pdf | |
10/07/2003 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21437se1-002_inspra_lbl.pdf | |
09/27/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21437lbl.pdf |
INSPRA
TABLET;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EPLERENONE | EPLERENONE | 25MG | TABLET;ORAL | Prescription | No | AB | 206922 | ACCORD HLTHCARE |
EPLERENONE | EPLERENONE | 25MG | TABLET;ORAL | Prescription | No | AB | 213812 | ANNORA PHARMA |
EPLERENONE | EPLERENONE | 25MG | TABLET;ORAL | Prescription | No | AB | 208283 | BRECKENRIDGE |
EPLERENONE | EPLERENONE | 25MG | TABLET;ORAL | Prescription | No | AB | 078482 | CHARTWELL RX |
EPLERENONE | EPLERENONE | 25MG | TABLET;ORAL | Prescription | No | AB | 203896 | PRASCO |
EPLERENONE | EPLERENONE | 25MG | TABLET;ORAL | Prescription | No | AB | 214663 | RISING |
EPLERENONE | EPLERENONE | 25MG | TABLET;ORAL | Prescription | No | AB | 078510 | SANDOZ |
EPLERENONE | EPLERENONE | 25MG | TABLET;ORAL | Prescription | No | AB | 212765 | SLATE RUN PHARMA |
EPLERENONE | EPLERENONE | 25MG | TABLET;ORAL | Prescription | No | AB | 207842 | WESTMINSTER PHARMS |
INSPRA | EPLERENONE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 021437 | UPJOHN |
TABLET;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EPLERENONE | EPLERENONE | 50MG | TABLET;ORAL | Prescription | No | AB | 206922 | ACCORD HLTHCARE |
EPLERENONE | EPLERENONE | 50MG | TABLET;ORAL | Prescription | No | AB | 213812 | ANNORA PHARMA |
EPLERENONE | EPLERENONE | 50MG | TABLET;ORAL | Prescription | No | AB | 208283 | BRECKENRIDGE |
EPLERENONE | EPLERENONE | 50MG | TABLET;ORAL | Prescription | No | AB | 078482 | CHARTWELL RX |
EPLERENONE | EPLERENONE | 50MG | TABLET;ORAL | Prescription | No | AB | 203896 | PRASCO |
EPLERENONE | EPLERENONE | 50MG | TABLET;ORAL | Prescription | No | AB | 214663 | RISING |
EPLERENONE | EPLERENONE | 50MG | TABLET;ORAL | Prescription | No | AB | 078510 | SANDOZ |
EPLERENONE | EPLERENONE | 50MG | TABLET;ORAL | Prescription | No | AB | 212765 | SLATE RUN PHARMA |
EPLERENONE | EPLERENONE | 50MG | TABLET;ORAL | Prescription | No | AB | 207842 | WESTMINSTER PHARMS |
INSPRA | EPLERENONE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 021437 | UPJOHN |