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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204763
Company: NOVEL LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBIDOPA CARBIDOPA 25MG 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
10/20/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

CARBIDOPA

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBIDOPA CARBIDOPA 25MG TABLET;ORAL Prescription No AB 204291 ALVOGEN
CARBIDOPA CARBIDOPA 25MG TABLET;ORAL Prescription No AB 211055 AUROBINDO PHARMA LTD
CARBIDOPA CARBIDOPA 25MG TABLET;ORAL Prescription No AB 205304 EDENBRIDGE PHARMS
CARBIDOPA CARBIDOPA 25MG TABLET;ORAL Prescription No AB 204763 NOVEL LABS INC
CARBIDOPA CARBIDOPA 25MG TABLET;ORAL Prescription No AB 209910 ZYDUS PHARMS
LODOSYN CARBIDOPA 25MG TABLET;ORAL Prescription Yes AB 017830 ATON
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