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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208522
Company: ACTAVIS LABS FL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 23.75MG;95MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 36.25MG;145MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 48.75MG;195MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 61.25MG;245MG CAPSULE, EXTENDED RELEASE;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
11/02/2026 ORIG-1 Approval STANDARD

Label is not available on this site.

CARBIDOPA AND LEVODOPA

CAPSULE, EXTENDED RELEASE;ORAL; 23.75MG;95MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 23.75MG;95MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 208522 ACTAVIS LABS FL
RYTARY CARBIDOPA; LEVODOPA 23.75MG;95MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 203312 IMPAX

CAPSULE, EXTENDED RELEASE;ORAL; 36.25MG;145MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 36.25MG;145MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 208522 ACTAVIS LABS FL
RYTARY CARBIDOPA; LEVODOPA 36.25MG;145MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 203312 IMPAX

CAPSULE, EXTENDED RELEASE;ORAL; 48.75MG;195MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 48.75MG;195MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 208522 ACTAVIS LABS FL
RYTARY CARBIDOPA; LEVODOPA 48.75MG;195MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 203312 IMPAX

CAPSULE, EXTENDED RELEASE;ORAL; 61.25MG;245MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 61.25MG;245MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 208522 ACTAVIS LABS FL
RYTARY CARBIDOPA; LEVODOPA 61.25MG;245MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 203312 IMPAX
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