Approvals (Drugs@FDA)

ZANAFLEX

LEGACY · TIZANIDINE HYDROCHLORIDE

NDA020397Drug (NDA)DiscontinuedPrescription
Open FDA's page for this record
Application number
NDA020397
Sponsor name
LEGACY
Submissions
  1. Submission type
    SUPPL
    Submission number
    5
    Submission status
    AP
    Submission status date
    19990615
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  2. Submission type
    SUPPL
    Submission number
    29
    Submission status
    AP
    Submission status date
    20241122
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      80331
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020397Orig1s029,021447Orig1s017lbl.pdf
      Date
      20250121
      Type
      Label
    2. ID
      80432
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020397Orig1s029,021447Orig1s017ltr.pdf
      Date
      20241126
      Type
      Letter
  3. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    19971023
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  4. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    19970902
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  5. Submission type
    SUPPL
    Submission number
    25
    Submission status
    AP
    Submission status date
    20160527
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  6. Submission type
    SUPPL
    Submission number
    23
    Submission status
    AP
    Submission status date
    20130319
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      24903
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020397Orig1s023ltr.pdf
      Date
      20130321
      Type
      Letter
  7. Submission type
    SUPPL
    Submission number
    15
    Submission status
    AP
    Submission status date
    20020410
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  8. Submission type
    SUPPL
    Submission number
    21
    Submission status
    AP
    Submission status date
    20060728
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      12534
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020397s021,021447s002lbl.pdf
      Date
      20060804
      Type
      Label
    2. ID
      2474
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020397s021, 021447s002LTR.pdf
      Date
      20060804
      Type
      Letter
  9. Submission type
    SUPPL
    Submission number
    13
    Submission status
    AP
    Submission status date
    20010822
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  10. Submission type
    SUPPL
    Submission number
    11
    Submission status
    AP
    Submission status date
    20010320
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  11. Submission type
    SUPPL
    Submission number
    8
    Submission status
    AP
    Submission status date
    20000821
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  12. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    20000204
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
    Application docs
    1. ID
      41331
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020397_S004_ZANAFLEX TABLETS_AP.pdf
      Date
      20070709
      Type
      Review
  13. +9 more not shown
Products
  1. Product number
    002
    Reference drug
    Yes
    Brand name
    ZANAFLEX
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Active ingredients
    1. Name
      TIZANIDINE HYDROCHLORIDE
      Strength
      EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  2. Product number
    001
    Reference drug
    Yes
    Brand name
    ZANAFLEX
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      TIZANIDINE HYDROCHLORIDE
      Strength
      EQ 4MG BASE
Harmonized identifiers (openFDA)
Application number
NDA020397
Brand name
ZANAFLEX
Generic name
TIZANIDINE HYDROCHLORIDE
Manufacturer name
Covis Pharma US, Inc, Legacy Pharma USA, Inc.
Product NDC
70515-594, 70515-602, 70515-604, 70515-606, 83107-004, 83107-001, 83107-002, 83107-003
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
TIZANIDINE HYDROCHLORIDE
RxCUI
153735, 313413, 485484, 485485, 485486, 580267, 583165, 583211
SPL ID
3468e009-cfd1-f217-e063-6294a90a1429, 476ae6e6-0732-af36-e063-6394a90a7c02
SPL set ID
043d9e51-bfa2-4add-9058-5ece332f7e99, 60c27d35-7349-4fc6-86ad-70fffdbe3e08
Package NDC
70515-602-15, 70515-604-15, 70515-606-15, 70515-594-15, 83107-001-15, 83107-002-15, 83107-003-15, 83107-004-15
UNII
B53E3NMY5C
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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.