Approvals (Drugs@FDA)

TOPIRAMATE

AJANTA PHARMA LTD · TOPIRAMATE

ANDA215663Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA215663
Sponsor name
AJANTA PHARMA LTD
Submissions
  1. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    20261005
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    20250723
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20230815
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  4. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20240530
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    004
    Reference drug
    No
    Brand name
    TOPIRAMATE
    Reference standard
    No
    Dosage form
    CAPSULE, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB1
    Active ingredients
    1. Name
      TOPIRAMATE
      Strength
      200MG
  2. Product number
    002
    Reference drug
    No
    Brand name
    TOPIRAMATE
    Reference standard
    No
    Dosage form
    CAPSULE, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB1
    Active ingredients
    1. Name
      TOPIRAMATE
      Strength
      50MG
  3. Product number
    003
    Reference drug
    No
    Brand name
    TOPIRAMATE
    Reference standard
    No
    Dosage form
    CAPSULE, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB1
    Active ingredients
    1. Name
      TOPIRAMATE
      Strength
      100MG
  4. Product number
    001
    Reference drug
    No
    Brand name
    TOPIRAMATE
    Reference standard
    No
    Dosage form
    CAPSULE, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB1
    Active ingredients
    1. Name
      TOPIRAMATE
      Strength
      25MG
Harmonized identifiers (openFDA)
Application number
ANDA215663
Brand name
TOPIRAMATE
Generic name
TOPIRAMATE
Manufacturer name
Ajanta Pharma USA Inc.
Product NDC
27241-227, 27241-228, 27241-229, 27241-230
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
TOPIRAMATE
RxCUI
1436239, 1437278, 1437283, 1437288
SPL ID
6a92525c-bf1f-4a48-90a7-62e9baaa553d
SPL set ID
b94629e3-ae2e-473e-b2f5-06e32ee19aa9
Package NDC
27241-227-30, 27241-227-01, 27241-228-30, 27241-228-01, 27241-229-30, 27241-229-01, 27241-230-30, 27241-230-01
Nui
N0000008486, N0000185506, N0000182140
Pharm class pe
Decreased Central Nervous System Disorganized Electrical Activity [PE]
Pharm class moa
Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA]
UNII
0H73WJJ391
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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.