Approvals (Drugs@FDA)

DABIGATRAN ETEXILATE MESYLATE

MSN · DABIGATRAN ETEXILATE MESYLATE

ANDA213879Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA213879
Sponsor name
MSN
Submissions
  1. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20241001
    Review priority
    UNKNOWN
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240522
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      78835
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213879Orig1s000ltr.pdf
      Date
      20240620
      Type
      Letter
  3. Submission type
    ORIG
    Submission number
    2
    Submission status
    AP
    Submission status date
    20240812
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    003
    Reference drug
    No
    Brand name
    DABIGATRAN ETEXILATE MESYLATE
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DABIGATRAN ETEXILATE MESYLATE
      Strength
      EQ 110MG BASE
  2. Product number
    001
    Reference drug
    No
    Brand name
    DABIGATRAN ETEXILATE MESYLATE
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DABIGATRAN ETEXILATE MESYLATE
      Strength
      EQ 75MG BASE
  3. Product number
    002
    Reference drug
    No
    Brand name
    DABIGATRAN ETEXILATE MESYLATE
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DABIGATRAN ETEXILATE MESYLATE
      Strength
      EQ 150MG BASE
Harmonized identifiers (openFDA)
Application number
ANDA213879
Brand name
DABIGATRAN
Generic name
DABIGATRAN ETEXILATE
Manufacturer name
Novadoz Pharmaceuticals LLC, AvKARE
Product NDC
72205-202, 72205-204, 72205-203, 42291-033, 42291-034
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
DABIGATRAN ETEXILATE MESYLATE
RxCUI
1037045, 1037179, 1723476
SPL ID
50fb8204-a087-4f97-ab57-85773b8c0065, 484c020e-2b6b-98c8-e063-6294a90a1a73
SPL set ID
6f79088b-b353-485a-9df4-6f5088f5bd0f, 27e95caf-7938-ef8e-e063-6394a90a6a1a
Package NDC
72205-202-60, 72205-202-34, 72205-204-60, 72205-204-34, 72205-203-60, 72205-203-34, 42291-034-60, 42291-033-60
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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.