Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090690
Company: SUN PHARM
Company: SUN PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENTACAPONE | ENTACAPONE | 200MG | 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 |
---|---|---|---|---|---|---|---|
07/16/2012 | ORIG-1 | Approval |
Label is not available on this site. |
ENTACAPONE
TABLET;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
COMTAN | ENTACAPONE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 020796 | ORION PHARMA |
ENTACAPONE | ENTACAPONE | 200MG | TABLET;ORAL | Prescription | No | AB | 205792 | AJANTA PHARMA LTD |
ENTACAPONE | ENTACAPONE | 200MG | TABLET;ORAL | Prescription | No | AB | 212601 | ALEMBIC |
ENTACAPONE | ENTACAPONE | 200MG | TABLET;ORAL | Prescription | No | AB | 203437 | AUROBINDO PHARMA LTD |
ENTACAPONE | ENTACAPONE | 200MG | TABLET;ORAL | Prescription | No | AB | 207210 | MACLEODS PHARMS LTD |
ENTACAPONE | ENTACAPONE | 200MG | TABLET;ORAL | Prescription | No | AB | 090690 | SUN PHARM |
ENTACAPONE | ENTACAPONE | 200MG | TABLET;ORAL | Prescription | No | AB | 206669 | SUNSHINE |
ENTACAPONE | ENTACAPONE | 200MG | TABLET;ORAL | Prescription | No | AB | 078941 | WOCKHARDT BIO AG |