Approvals (Drugs@FDA)

RIVAROXABAN

TARO · RIVAROXABAN

ANDA208557Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA208557
Sponsor name
TARO
Submissions
  1. Submission type
    ORIG
    Submission number
    2
    Submission status
    AP
    Submission status date
    20251007
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250303
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    004
    Reference drug
    No
    Brand name
    RIVAROXABAN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      RIVAROXABAN
      Strength
      20MG
  2. Product number
    002
    Reference drug
    No
    Brand name
    RIVAROXABAN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      RIVAROXABAN
      Strength
      10MG
  3. Product number
    003
    Reference drug
    No
    Brand name
    RIVAROXABAN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      RIVAROXABAN
      Strength
      15MG
  4. Product number
    001
    Reference drug
    No
    Brand name
    RIVAROXABAN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      RIVAROXABAN
      Strength
      2.5MG
Harmonized identifiers (openFDA)
Application number
ANDA208557
Brand name
RIVAROXABAN
Generic name
RIVAROXABAN
Manufacturer name
Sun Pharmaceutical Industries, Inc.
Product NDC
51672-4228
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
RIVAROXABAN
RxCUI
2059015
SPL ID
52d1407e-403f-49ef-e063-6294a90ab543
SPL set ID
925a9a11-ae5b-405c-96d2-b1be4b85bf71
Package NDC
51672-4228-4, 51672-4228-9
Nui
N0000175635, N0000175637
Pharm class moa
Factor Xa Inhibitors [MoA]
Pharm class epc
Factor Xa Inhibitor [EPC]
UNII
9NDF7JZ4M3
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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.