Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206922
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EPLERENONE | EPLERENONE | 25MG | TABLET;ORAL | Prescription | AB | No | No |
EPLERENONE | EPLERENONE | 50MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
07/13/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/03/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
EPLERENONE
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 | 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 | 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 |