Approvals (Drugs@FDA)

CYCLOSPORINE

DEVA HOLDING AS · CYCLOSPORINE

ANDA209811Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA209811
Sponsor name
DEVA HOLDING AS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240521
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    CYCLOSPORINE
    Reference standard
    No
    Dosage form
    EMULSION
    Route
    OPHTHALMIC
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      CYCLOSPORINE
      Strength
      0.05%
Harmonized identifiers (openFDA)
Application number
ANDA209811
Brand name
CYCLOSPORINE
Generic name
CYCLOSPORINE
Manufacturer name
Devatis Inc.
Product NDC
73043-005
Product type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Substance name
CYCLOSPORINE
RxCUI
2572292
SPL ID
5135618a-f2f6-49bd-b0ea-636cb2adf84c
SPL set ID
7bb2078d-17c2-4e6a-9f61-26c7ecbce945
Package NDC
73043-005-01, 73043-005-02
Nui
N0000175457, N0000175458, N0000182141, N0000185503
Pharm class epc
Calcineurin Inhibitor Immunosuppressant [EPC]
Pharm class moa
Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
UNII
83HN0GTJ6D
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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.