Drugs@FDA: FDA-Approved Drugs
Company: CONCORDIA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DYRENIUM | TRIAMTERENE | 50MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| DYRENIUM | TRIAMTERENE | 100MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 08/10/1964 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/28/2002 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/1994 | SUPPL-58 | Labeling |
Label is not available on this site. |
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| 12/09/1992 | SUPPL-57 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/03/1992 | SUPPL-56 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 03/07/1990 | SUPPL-54 | Labeling |
Label is not available on this site. |
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| 11/09/1988 | SUPPL-53 | Labeling |
Label is not available on this site. |
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| 02/02/1988 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/29/1987 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 09/23/1987 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/25/1982 | SUPPL-46 | Labeling |
Label is not available on this site. |
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| 10/04/1985 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 07/14/1980 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 11/26/1979 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 11/12/1979 | SUPPL-41 | Labeling |
Label is not available on this site. |
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| 02/05/1981 | SUPPL-40 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/07/1979 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 11/16/1978 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 08/15/1978 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 12/12/1977 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/19/1978 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/19/1978 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/19/1978 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1978 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 05/22/1978 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 05/22/1978 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 02/14/1977 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/14/1977 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/01/1977 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 11/05/1976 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 09/03/1976 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 09/03/1976 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 01/14/1976 | SUPPL-21 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/03/1976 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 01/14/1976 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/02/1975 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/02/1975 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 01/14/1976 | SUPPL-16 | Unspecified |
Label is not available on this site. |
||
| 07/24/1975 | SUPPL-14 | Unspecified |
Label is not available on this site. |
||
| 06/02/1975 | SUPPL-11 | Unspecified |
Label is not available on this site. |
DYRENIUM
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 |