Approvals (Drugs@FDA)

AZMIRO

AZURITY · TESTOSTERONE CYPIONATE

NDA216318Drug (NDA)Discontinued
Open FDA's page for this record
Application number
NDA216318
Sponsor name
AZURITY
Submissions
  1. Submission type
    SUPPL
    Submission number
    5
    Submission status
    AP
    Submission status date
    20250711
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      82839
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216318s005lbl.pdf
      Date
      20250714
      Type
      Label
    2. ID
      82840
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216318s005lbl.pdf#page=18
      Date
      20250714
      Type
      Medication Guide
    3. ID
      82875
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216318Orig1s005ltr.pdf
      Date
      20250715
      Type
      Letter
  2. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20241218
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      80645
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216318Orig1s003ltr.pdf
      Date
      20241219
      Type
      Letter
    2. ID
      81684
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216318Orig1s003lbl.pdf
      Date
      20250324
      Type
      Label
  3. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20240201
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      77384
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216318Orig1s002ltr.pdf
      Date
      20240202
      Type
      Letter
    2. ID
      77386
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216318Orig1s002lbl.pdf
      Date
      20240304
      Type
      Label
  4. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20220602
    Review priority
    STANDARD
    Submission class code
    TYPE 5
    Submission class code description
    Type 5 - New Formulation or New Manufacturer
    Application docs
    1. ID
      71209
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216318Orig1s000ltr.pdf
      Date
      20220603
      Type
      Letter
    2. ID
      71210
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216318s000lbl.pdf
      Date
      20220603
      Type
      Label
    3. ID
      73619
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/216318Orig1s000TOC.html
      Date
      20230228
      Type
      Review
Products
  1. Product number
    001
    Reference drug
    Yes
    Brand name
    AZMIRO
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    INTRAMUSCULAR
    Marketing status
    Discontinued
    Active ingredients
    1. Name
      TESTOSTERONE CYPIONATE
      Strength
      200MG/ML (200MG/ML)
Harmonized identifiers (openFDA)
Application number
NDA216318
Brand name
AZMIRO
Generic name
TESTOSTERONE CYPIONATE
Manufacturer name
Azurity Pharmaceuticals, Inc.
Product NDC
24338-055, 24338-056
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAMUSCULAR
Substance name
TESTOSTERONE CYPIONATE
RxCUI
2047882, 2694309, 2694316, 2694320
SPL ID
5cf15fb2-1ba1-4295-9ddf-e98434ccd1c2
SPL set ID
235b5625-570d-3fba-e063-6394a90aa2d1
Package NDC
24338-056-01, 24338-055-01
UNII
M0XW1UBI14
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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.