Approvals (Drugs@FDA)

PREGABALIN

TORRENT · PREGABALIN

ANDA206942Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA206942
Sponsor name
TORRENT
Submissions
  1. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250707
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250221
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
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
Harmonized identifiers (openFDA)
Application number
ANDA206942
Brand name
PREGABALIN
Generic name
PREGABALIN
Manufacturer name
Torrent Pharmaceuticals Limited
Product NDC
13668-358, 13668-359, 13668-360, 13668-361, 13668-362, 13668-363, 13668-364, 13668-365
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
PREGABALIN
RxCUI
483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127
SPL ID
f28a120a-aea5-45b9-84f7-06f48f41bc03
SPL set ID
a062e78a-16ff-4d83-b700-0badb7d812d5
Package NDC
13668-359-30, 13668-359-60, 13668-359-01, 13668-359-05, 13668-360-30, 13668-360-90, 13668-360-01, 13668-360-05, 13668-361-30, 13668-361-01, 13668-361-60, 13668-361-05, 13668-362-30, 13668-362-90, 13668-362-01, 13668-362-05, 13668-363-30, 13668-363-60, 13668-363-01, 13668-363-05, 13668-364-30, 13668-364-60, 13668-364-01, 13668-364-05, 13668-365-30, 13668-365-60, 13668-365-01, 13668-365-05, 13668-365-02, 13668-358-30, 13668-358-60, 13668-358-01, 13668-358-05
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.