Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216505
Company: RUBICON
Company: RUBICON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | AB | No | No |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | AB | No | No |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | 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 |
---|---|---|---|---|---|---|---|
09/21/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CARBIDOPA AND LEVODOPA
TABLET;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;ORAL | Prescription | No | AB | 074260 | ACTAVIS ELIZABETH |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 077120 | APOTEX INC |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 216537 | AUROBINDO PHARMA LTD |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 073618 | DR REDDYS LABS SA |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 090324 | MYLAN |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 216505 | RUBICON |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 214092 | SCIEGEN PHARMS INC |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | No | AB | 078536 | SUN PHARM INDS |
SINEMET | CARBIDOPA; LEVODOPA | 10MG;100MG | TABLET;ORAL | Prescription | Yes | AB | 017555 | ORGANON |
TABLET;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;ORAL | Prescription | No | AB | 074260 | ACTAVIS ELIZABETH |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 077120 | APOTEX INC |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 216537 | AUROBINDO PHARMA LTD |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 073589 | DR REDDYS LABS SA |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 090324 | MYLAN |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 216505 | RUBICON |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 214092 | SCIEGEN PHARMS INC |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 078536 | SUN PHARM INDS |
SINEMET | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET;ORAL | Prescription | Yes | AB | 017555 | ORGANON |
TABLET;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;ORAL | Prescription | No | AB | 074260 | ACTAVIS ELIZABETH |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 077120 | APOTEX INC |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 216537 | AUROBINDO PHARMA LTD |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 073607 | DR REDDYS LABS SA |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 090324 | MYLAN |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 216505 | RUBICON |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 214092 | SCIEGEN PHARMS INC |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | No | AB | 078536 | SUN PHARM INDS |
SINEMET | CARBIDOPA; LEVODOPA | 25MG;250MG | TABLET;ORAL | Prescription | Yes | AB | 017555 | ORGANON |