Approvals (Drugs@FDA)

ONYDA XR

TRIS PHARMA INC · CLONIDINE HYDROCHLORIDE

NDA217645Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA217645
Sponsor name
TRIS PHARMA INC
Submissions
  1. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    20250507
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      82186
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217645Orig1s004ltr.pdf
      Date
      20250514
      Type
      Letter
    2. ID
      82257
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217645s004lbl.pdf
      Date
      20250507
      Type
      Label
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240524
    Review priority
    STANDARD
    Submission class code
    TYPE 3
    Submission class code description
    Type 3 - New Dosage Form
    Application docs
    1. ID
      78560
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217645s000lbl.pdf
      Date
      20240528
      Type
      Label
    2. ID
      78564
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217645Orig1s000ltr.pdf
      Date
      20240528
      Type
      Letter
    3. ID
      79731
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217645Orig1s000TOC.html
      Date
      20240925
      Type
      Review
  3. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20241206
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      80537
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217645Orig1s001ltr.pdf
      Date
      20241209
      Type
      Letter
    2. ID
      80543
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217645s001lbl.pdf
      Date
      20241210
      Type
      Label
Products
  1. Product number
    001
    Reference drug
    Yes
    Brand name
    ONYDA XR
    Reference standard
    Yes
    Dosage form
    SUSPENSION, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      CLONIDINE HYDROCHLORIDE
      Strength
      0.1MG/ML
Harmonized identifiers (openFDA)
Application number
NDA217645
Brand name
ONYDA XR
Generic name
CLONIDINE HYDROCHLORIDE
Manufacturer name
NextWave Pharmaceuticals, Inc
Product NDC
24478-148
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
CLONIDINE HYDROCHLORIDE
RxCUI
2690727, 2690735
SPL ID
00de799f-c9cb-42b7-8471-5bde35108200
SPL set ID
4a15c850-9da5-4bdc-a34d-7f740a6149b7
Package NDC
24478-148-01, 24478-148-02, 24478-148-03, 24478-148-04
UNII
W76I6XXF06
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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.