Approvals (Drugs@FDA)

MICAFUNGIN SODIUM

BIOCON PHARMA · MICAFUNGIN SODIUM

ANDA216438Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA216438
Sponsor name
BIOCON PHARMA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240529
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    MICAFUNGIN SODIUM
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      MICAFUNGIN SODIUM
      Strength
      EQ 50MG BASE/VIAL
  2. Product number
    002
    Reference drug
    No
    Brand name
    MICAFUNGIN SODIUM
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      MICAFUNGIN SODIUM
      Strength
      EQ 100MG BASE/VIAL
Harmonized identifiers (openFDA)
Application number
ANDA216438
Brand name
MICAFUNGIN
Generic name
MICAFUNGIN
Manufacturer name
Biocon Pharma Inc.
Product NDC
70377-075, 70377-076
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Substance name
MICAFUNGIN SODIUM
RxCUI
861379, 861383
SPL ID
94972438-1ece-f99c-c2a5-e29821e7e9d4
SPL set ID
5a74d7e9-1ca2-37dd-cbcf-d7fde1f5a606
Package NDC
70377-075-91, 70377-076-91
UNII
IS1UP79R56
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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.