Approvals (Drugs@FDA)

PREGABALIN

REGCON HOLDINGS · PREGABALIN

ANDA208113Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA208113
Sponsor name
REGCON HOLDINGS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240517
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  2. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20250815
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
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
      100MG
  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
      150MG
  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
      75MG
  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
Harmonized identifiers (openFDA)
Application number
ANDA208113
Brand name
PREGABALIN
Generic name
PREGABALIN
Manufacturer name
Indoco Remedies Limited
Product NDC
14445-123, 14445-173, 14445-174, 14445-124, 14445-125, 14445-126, 14445-127, 14445-128
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
PREGABALIN
RxCUI
483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127
SPL ID
522b3d6c-10fb-4581-afb7-2e48150b6048
SPL set ID
0a8d9e35-46fd-4c70-bb7f-4e8b754f2794
Package NDC
14445-173-90, 14445-174-90, 14445-174-10, 14445-174-00, 14445-123-90, 14445-123-10, 14445-123-00, 14445-124-90, 14445-124-10, 14445-124-00, 14445-125-90, 14445-125-10, 14445-125-00, 14445-126-90, 14445-127-90, 14445-128-90
UNII
55JG375S6M
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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.