Drugs@FDA: FDA-Approved Drugs
Company: DR REDDYS LABS SA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIMETHOPRIM | TRIMETHOPRIM | 100MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 07/30/1982 | 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 |
|---|---|---|---|---|---|
| 06/13/2016 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018679s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018679Orig1s044ltr.pdf |
| 08/11/2016 | SUPPL-43 |
Label is not available on this site. |
|||
| 07/12/2012 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018679s040lbl.pdf | |
| 02/11/2008 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 06/18/2003 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 05/15/2002 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/2002 | SUPPL-32 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/15/2002 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 05/15/2002 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/15/2002 | SUPPL-29 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/15/2002 | SUPPL-28 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-26 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/06/1997 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 04/16/1997 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/1996 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 03/01/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/27/1987 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/27/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/08/1986 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1986 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1986 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/13/2016 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018679s044lbl.pdf |
| 07/12/2012 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018679s040lbl.pdf |
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 |