Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211581
Company: AGNITIO
Company: AGNITIO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRIAMTERENE | TRIAMTERENE | 50MG | CAPSULE;ORAL | Prescription | AB | No | No |
TRIAMTERENE | TRIAMTERENE | 100MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
08/19/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211581Orig1s000ltr.pdf |
TRIAMTERENE
CAPSULE;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DYRENIUM | TRIAMTERENE | 50MG | CAPSULE;ORAL | Prescription | Yes | AB | 013174 | CONCORDIA |
TRIAMTERENE | TRIAMTERENE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 211581 | AGNITIO |
CAPSULE;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DYRENIUM | TRIAMTERENE | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 013174 | CONCORDIA |
TRIAMTERENE | TRIAMTERENE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 211581 | AGNITIO |