Approvals (Drugs@FDA)

CARBIDOPA AND LEVODOPA

RUBICON RESEARCH · CARBIDOPA, LEVODOPA

ANDA217482Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA217482
Sponsor name
RUBICON RESEARCH
Submissions
  1. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20260528
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240604
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    CARBIDOPA AND LEVODOPA
    Reference standard
    No
    Dosage form
    TABLET, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      CARBIDOPA
      Strength
      50MG
    2. Name
      LEVODOPA
      Strength
      200MG
  2. Product number
    001
    Reference drug
    No
    Brand name
    CARBIDOPA AND LEVODOPA
    Reference standard
    No
    Dosage form
    TABLET, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      CARBIDOPA
      Strength
      25MG
    2. Name
      LEVODOPA
      Strength
      100MG
Harmonized identifiers (openFDA)
Application number
ANDA217482
Brand name
CARBIDOPA AND LEVODOPA
Generic name
CARBIDOPA AND LEVODOPA
Manufacturer name
Advagen Pharma Ltd
Product NDC
72888-155, 72888-156
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
CARBIDOPA, LEVODOPA
RxCUI
308988, 308989
SPL ID
519a4143-7efb-81ab-e063-6394a90a219b
SPL set ID
5b6519ff-d1af-402b-83eb-b4fce6743a18
Package NDC
72888-155-30, 72888-155-01, 72888-155-05, 72888-155-00, 72888-156-30, 72888-156-01, 72888-156-05, 72888-156-00
Nui
N0000193220, M0370111, N0000175754, N0000175755
Pharm class epc
Aromatic Amino Acid [EPC], Aromatic Amino Acid Decarboxylation Inhibitor [EPC]
Pharm class cs
Amino Acids, Aromatic [CS]
Pharm class moa
DOPA Decarboxylase Inhibitors [MoA]
UNII
46627O600J, MNX7R8C5VO
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.