Approvals (Drugs@FDA)

ARFORMOTEROL TARTRATE

MICRO LABS · ARFORMOTEROL TARTRATE

ANDA218555Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA218555
Sponsor name
MICRO LABS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250307
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    ARFORMOTEROL TARTRATE
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    INHALATION
    Marketing status
    Prescription
    Te code
    AN
    Active ingredients
    1. Name
      ARFORMOTEROL TARTRATE
      Strength
      EQ 0.015MG BASE/2ML
Harmonized identifiers (openFDA)
Application number
ANDA218555
Brand name
ARFORMOTEROL TARTRATE
Generic name
ARFORMOTEROL TARTRATE
Manufacturer name
Micro Labs Limited
Product NDC
42571-464
Product type
HUMAN PRESCRIPTION DRUG
Route
RESPIRATORY (INHALATION)
Substance name
ARFORMOTEROL TARTRATE
RxCUI
668956
SPL ID
3306ffee-e664-1534-e063-6294a90ad7ba
SPL set ID
6838a595-19cc-454a-96b9-ff83b93881ae
Package NDC
42571-464-75, 42571-464-73
UNII
5P8VJ2I235
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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.