Approvals (Drugs@FDA)

TIVICAY PD

VIIV HLTHCARE · DOLUTEGRAVIR SODIUM

NDA213983Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA213983
Sponsor name
VIIV HLTHCARE
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20200612
    Review priority
    PRIORITY
    Submission class code
    TYPE 3
    Submission class code description
    Type 3 - New Dosage Form
    Application docs
    1. ID
      63566
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213983s000lbl.pdf
      Date
      20200615
      Type
      Label
    2. ID
      63574
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213983Orig1s000ltr.pdf
      Date
      20200616
      Type
      Letter
    3. ID
      65174
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213983Orig1s000TOC.html
      Date
      20201109
      Type
      Review
  2. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    20251028
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      83983
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204790Orig1s033;213983Orig1s006ltr.pdf
      Date
      20251029
      Type
      Letter
    2. ID
      83991
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213983s006lbl.pdf
      Date
      20251029
      Type
      Label
  3. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    20240418
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      78162
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204790s031,213983s004lbl.pdf
      Date
      20240419
      Type
      Label
    2. ID
      78171
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204790Orig1s031; 213983Orig1s004ltr.pdf
      Date
      20240419
      Type
      Letter
  4. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20210709
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      68051
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204790s028,213983s002lbl.pdf
      Date
      20210712
      Type
      Label
    2. ID
      68063
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204790Orig1s028; 213983Orig1s002ltr.pdf
      Date
      20210713
      Type
      Letter
  5. Submission type
    SUPPL
    Submission number
    7
    Submission status
    AP
    Submission status date
    20260825
    Review priority
    PRIORITY
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      87046
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/204790Orig1s034,213983Orig1s007ltr.pdf
      Date
      20260827
      Type
      Letter
    2. ID
      87088
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213983s007lbl.pdf
      Date
      20260901
      Type
      Label
  6. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20221007
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      72286
      Date
      20221011
      Type
      Letter
      Url

      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204790Orig1s030,213983Orig1s003ltr.pdf

    2. ID
      72299
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204790s030,213983s003lbl.pdf
      Date
      20221011
      Type
      Label
  7. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20210323
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      66856
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204790Orig1s029,213983Orig1s001ltr.pdf
      Date
      20210324
      Type
      Letter
    2. ID
      66864
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204790s029,213983s001lbl.pdf
      Date
      20210325
      Type
      Label
Products
  1. Product number
    001
    Reference drug
    Yes
    Brand name
    TIVICAY PD
    Reference standard
    Yes
    Dosage form
    TABLET, FOR SUSPENSION
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      DOLUTEGRAVIR SODIUM
      Strength
      EQ 5MG BASE
Harmonized identifiers (openFDA)
Application number
NDA213983
Brand name
TIVICAY PD
Generic name
DOLUTEGRAVIR SODIUM
Manufacturer name
ViiV Healthcare Company
Product NDC
49702-255, 49702-226, 49702-227, 49702-228
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
DOLUTEGRAVIR SODIUM
RxCUI
1433873, 1433879, 1796077, 1796079, 1796081, 1796083, 2374562, 2374566
SPL ID
edfff6ba-b810-49ff-a578-f03b9544e886
SPL set ID
63df5af3-b8ac-4e76-9830-2dbb340af922
Package NDC
49702-255-37, 49702-226-13, 49702-227-13, 49702-228-13
UNII
1Q1V9V5WYQ
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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.