Approvals (Drugs@FDA)

MILNACIPRAN HYDROCHLORIDE

MACLEODS PHARMS · MILNACIPRAN HYDROCHLORIDE

ANDA210944Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA210944
Sponsor name
MACLEODS PHARMS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260915
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      86104
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/210944Orig1s000TAltr.pdf
      Date
      20260602
      Type
      Letter
Products
  1. Product number
    003
    Reference drug
    No
    Brand name
    MILNACIPRAN HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      MILNACIPRAN HYDROCHLORIDE
      Strength
      50MG
  2. Product number
    001
    Reference drug
    No
    Brand name
    MILNACIPRAN HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      MILNACIPRAN HYDROCHLORIDE
      Strength
      12.5MG
  3. Product number
    004
    Reference drug
    No
    Brand name
    MILNACIPRAN HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      MILNACIPRAN HYDROCHLORIDE
      Strength
      100MG
  4. Product number
    002
    Reference drug
    No
    Brand name
    MILNACIPRAN HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      MILNACIPRAN HYDROCHLORIDE
      Strength
      25MG
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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.