Approvals (Drugs@FDA)

VENXXIVA

TORRENT · TIOPRONIN

ANDA216990Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA216990
Sponsor name
TORRENT
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240130
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      77490
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216990Orig1s000ltr.pdf
      Date
      20240214
      Type
      Letter
  2. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240726
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    VENXXIVA
    Reference standard
    No
    Dosage form
    TABLET, DELAYED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      TIOPRONIN
      Strength
      100MG
  2. Product number
    002
    Reference drug
    No
    Brand name
    VENXXIVA
    Reference standard
    No
    Dosage form
    TABLET, DELAYED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      TIOPRONIN
      Strength
      300MG
Harmonized identifiers (openFDA)
Application number
ANDA216990
Brand name
VENXXIVA, TIOPRONIN
Generic name
TIOPRONIN
Manufacturer name
Cycle Pharmaceuticals Ltd., Torrent Pharmaceuticals Limited
Product NDC
70709-121, 70709-123, 13668-691, 13668-692
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
TIOPRONIN
RxCUI
2178075, 2178079, 2702682, 2702684
SPL ID
c8eeb4d4-9718-41ba-b4fe-3d645fd60a20, b56545da-a8ae-437a-9757-44862a6d95f0
SPL set ID
02e24443-04c6-4b98-a395-49aec4a468de, ad750031-08ec-4d92-af2d-97a80c454e14
Package NDC
70709-121-30, 70709-123-90, 13668-691-03, 13668-692-90
Nui
N0000175549, M0289359, N0000175898
Pharm class moa
Cystine Disulfide Reduction [MoA]
Pharm class cs
N-substituted Glycines [CS]
Pharm class epc
Reducing and Complexing Thiol [EPC]
UNII
C5W04GO61S
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

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.