Approvals (Drugs@FDA)

GARZULYS

EMERGE BIOSCIENCE PTE. LTD. · INSULIN ASPART-FSAN

BLA761497Biologic (BLA)Prescription
Open FDA's page for this record
Application number
BLA761497
Sponsor name
EMERGE BIOSCIENCE PTE. LTD.
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260724
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      86724
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761497Orig1s000ltr.pdf
      Date
      20260728
      Type
      Letter
    2. ID
      86725
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761497s000lbl.pdf
      Date
      20260916
      Type
      Label
  2. Submission type
    ORIG
    Submission number
    2
    Submission status
    AP
    Submission status date
    20260915
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      87207
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761497Orig2s000ltr.pdf
      Date
      20260916
      Type
      Letter
    2. ID
      87239
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761497Orig2s000lbl.pdf
      Date
      20260922
      Type
      Label
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    GARZULYS
    Reference standard
    No
    Dosage form
    VIAL
    Route
    MULTIDOSE
    Marketing status
    Prescription
    Active ingredients
    1. Name
      INSULIN ASPART-FSAN
      Strength
      10ML
  2. Product number
    001
    Reference drug
    No
    Brand name
    GARZULYS
    Reference standard
    No
    Dosage form
    PEN
    Route
    PREFILLED
    Marketing status
    Prescription
    Active ingredients
    1. Name
      INSULIN ASPART-FSAN
      Strength
      3ML
Harmonized identifiers (openFDA)
Application number
BLA761497
Brand name
GARZULYS, INSULIN DILUTING MEDIUM FOR GARZULYS
Generic name
INSULIN ASPART-FSAN, WATER INJECTION
Manufacturer name
Meitheal Pharmaceuticals Inc.
Product NDC
71288-903, 71288-904, 71288-909
Product type
HUMAN PRESCRIPTION DRUG
Route
SUBCUTANEOUS, INTRAVENOUS
Substance name
INSULIN ASPART, WATER
RxCUI
2748451, 2748457, 2748459, 2748463
SPL ID
dbc6ea33-ff54-44b2-9ac7-cd76b4cb9c43
SPL set ID
30c64769-d2f7-4604-ac9e-2a6bc09506c9
Package NDC
71288-904-10, 71288-909-10, 71288-903-80, 71288-903-81
Nui
M0011417, N0000175453
Pharm class cs
Insulin [CS]
Pharm class epc
Insulin Analog [EPC]
UNII
059QF0KO0R, D933668QVX
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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.