Approvals (Drugs@FDA)

MIMRYLO

TAKEDA PHARMS AM · RUSFERTIDE ACETATE

NDA220605Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA220605
Sponsor name
TAKEDA PHARMS AM
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260828
    Review priority
    PRIORITY
    Submission class code
    TYPE 1
    Submission class code description
    Type 1 - New Molecular Entity
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      87083
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220605Orig1s000ltr.pdf
      Date
      20260901
      Type
      Letter
    2. ID
      87117
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220605Orig1s000lbl.pdf
      Date
      20260901
      Type
      Label
Products
  1. Product number
    005
    Reference drug
    Yes
    Brand name
    MIMRYLO
    Reference standard
    Yes
    Dosage form
    POWDER
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      RUSFERTIDE ACETATE
      Strength
      EQ 54MG BASE/VIAL
  2. Product number
    003
    Reference drug
    Yes
    Brand name
    MIMRYLO
    Reference standard
    Yes
    Dosage form
    POWDER
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      RUSFERTIDE ACETATE
      Strength
      EQ 28MG BASE/VIAL
  3. Product number
    001
    Reference drug
    Yes
    Brand name
    MIMRYLO
    Reference standard
    Yes
    Dosage form
    POWDER
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      RUSFERTIDE ACETATE
      Strength
      EQ 9.5MG BASE/VIAL
  4. Product number
    004
    Reference drug
    Yes
    Brand name
    MIMRYLO
    Reference standard
    Yes
    Dosage form
    POWDER
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      RUSFERTIDE ACETATE
      Strength
      EQ 41MG BASE/VIAL
  5. Product number
    002
    Reference drug
    Yes
    Brand name
    MIMRYLO
    Reference standard
    Yes
    Dosage form
    POWDER
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      RUSFERTIDE ACETATE
      Strength
      EQ 19MG BASE/VIAL
Harmonized identifiers (openFDA)
Application number
NDA220605
Brand name
MIMRYLO
Generic name
RUSFERTIDE
Manufacturer name
Takeda Pharmaceuticals America, Inc.
Product NDC
63020-715, 63020-725, 63020-735, 63020-745, 63020-765
Product type
HUMAN PRESCRIPTION DRUG
Route
SUBCUTANEOUS
RxCUI
2751601, 2751606, 2751608, 2751610, 2751612, 2751614, 2751616, 2751618, 2751620, 2751622
SPL ID
2fc41c37-8a81-4171-a52c-e9317c0c34cf
SPL set ID
101aff01-31ed-4841-a8b6-0a5a8503189b
Package NDC
63020-715-10, 63020-710-10, 63020-600-05, 63020-725-20, 63020-720-20, 63020-735-30, 63020-730-30, 63020-745-40, 63020-740-40, 63020-765-60, 63020-760-60
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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.