Approvals (Drugs@FDA)

PREGABALIN

PHARMOBEDIENT · PREGABALIN

ANDA091222Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA091222
Sponsor name
PHARMOBEDIENT
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250221
Products
  1. Product number
    007
    Reference drug
    No
    Brand name
    PREGABALIN
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      PREGABALIN
      Strength
      225MG
  2. Product number
    005
    Reference drug
    No
    Brand name
    PREGABALIN
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      PREGABALIN
      Strength
      150MG
  3. Product number
    003
    Reference drug
    No
    Brand name
    PREGABALIN
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      PREGABALIN
      Strength
      75MG
  4. Product number
    001
    Reference drug
    No
    Brand name
    PREGABALIN
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      PREGABALIN
      Strength
      25MG
  5. Product number
    008
    Reference drug
    No
    Brand name
    PREGABALIN
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      PREGABALIN
      Strength
      300MG
  6. Product number
    006
    Reference drug
    No
    Brand name
    PREGABALIN
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      PREGABALIN
      Strength
      200MG
  7. Product number
    004
    Reference drug
    No
    Brand name
    PREGABALIN
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      PREGABALIN
      Strength
      100MG
  8. Product number
    002
    Reference drug
    No
    Brand name
    PREGABALIN
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      PREGABALIN
      Strength
      50MG
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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.