Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070049
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIMETHOPRIM | TRIMETHOPRIM | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/06/1985 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/27/2015 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/21/2007 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/01/2002 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/25/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/02/2001 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/26/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 12/23/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
TRIMETHOPRIM
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TRIMETHOPRIM | TRIMETHOPRIM | 100MG | TABLET;ORAL | Prescription | Yes | AB | 018679 | DR REDDYS LABS SA |
| TRIMETHOPRIM | TRIMETHOPRIM | 100MG | TABLET;ORAL | Prescription | No | AB | 091437 | NOVEL LABS INC |
| TRIMETHOPRIM | TRIMETHOPRIM | 100MG | TABLET;ORAL | Prescription | No | AB | 216393 | NOVITIUM PHARMA |
| TRIMETHOPRIM | TRIMETHOPRIM | 100MG | TABLET;ORAL | Prescription | No | AB | 070049 | WATSON LABS |