Approvals (Drugs@FDA)

ARFORMOTEROL TARTRATE

DR REDDYS · ARFORMOTEROL TARTRATE

ANDA215032Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA215032
Sponsor name
DR REDDYS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240603
    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
ANDA215032
Brand name
ARFORMOTEROL TARTRATE
Generic name
ARFORMOTEROL TARTRATE
Manufacturer name
Dr. Reddy's Laboratories, Inc.
Product NDC
43598-777
Product type
HUMAN PRESCRIPTION DRUG
Route
RESPIRATORY (INHALATION)
Substance name
ARFORMOTEROL TARTRATE
RxCUI
668956
SPL ID
a718ab1b-b96b-bed2-24d1-b74c0277daed
SPL set ID
d8843369-b0d5-6f0d-1fcd-0c49002df755
Package NDC
43598-777-48, 43598-777-60, 43598-777-11, 43598-777-30
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.