Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078893
Company: RISING
Company: RISING
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 09/18/2008 | 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 |
|---|---|---|---|---|---|
| 03/07/2025 | SUPPL-9 | Labeling-Package Insert |
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 | 078893 | RISING |
| 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 | 078893 | RISING |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078690 | SUN PHARM |
TABLET, ORALLY DISINTEGRATING;ORAL; 25MG;250MG
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;250MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078893 | RISING |
| CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078690 | SUN PHARM |