Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091437
Company: NOVEL LABS INC
Company: NOVEL LABS INC
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 |
---|---|---|---|---|---|---|---|
06/15/2011 | 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 |
---|---|---|---|---|---|
10/19/2015 | SUPPL-1 | Labeling-Package Insert |
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 |