Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078690
Company: SUN PHARM
Company: SUN PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | None | No | 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 |
---|---|---|---|---|---|---|---|
07/31/2009 | ORIG-1 | Approval |
Label is not available on this site. |
CARBIDOPA AND LEVODOPA
TABLET, ORALLY DISINTEGRATING;ORAL; 10MG;100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078690 | SUN PHARM |
TABLET, ORALLY DISINTEGRATING;ORAL; 25MG;100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078690 | SUN PHARM |