Approvals (Drugs@FDA)

ALENDRONATE SODIUM

PRECISION DOSE INC · ALENDRONATE SODIUM

ANDA214523Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA214523
Sponsor name
PRECISION DOSE INC
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260902
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      87153
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/214523Orig1s000ltr.pdf
      Date
      20260904
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    ALENDRONATE SODIUM
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AA
    Active ingredients
    1. Name
      ALENDRONATE SODIUM
      Strength
      EQ 70MG BASE/75ML
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

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.