Approvals (Drugs@FDA)

POSACONAZOLE

MSN · POSACONAZOLE

ANDA218434Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA218434
Sponsor name
MSN
Submissions
  1. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20251029
    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
    20250224
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    POSACONAZOLE
    Reference standard
    No
    Dosage form
    TABLET, DELAYED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      POSACONAZOLE
      Strength
      100MG
Harmonized identifiers (openFDA)
Application number
ANDA218434
Brand name
POSACONAZOLE
Generic name
POSACONAZOLE
Manufacturer name
Novadoz Pharmaceuticals LLC
Product NDC
72205-168
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
POSACONAZOLE
RxCUI
1482908
SPL ID
0bdf77ae-3639-49c1-b7c7-533f9d073084
SPL set ID
0bdf77ae-3639-49c1-b7c7-533f9d073084
Package NDC
72205-168-60
Nui
N0000175487, M0002083
Pharm class epc
Azole Antifungal [EPC]
Pharm class cs
Azoles [CS]
UNII
6TK1G07BHZ
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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.