Approvals (Drugs@FDA)

ETCAMAH

ASTRAZENECA PHARMACEUTICALS, LP · CAMIZESTRANT

NDA220359Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA220359
Sponsor name
ASTRAZENECA PHARMACEUTICALS, LP
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260904
    Review priority
    STANDARD
    Submission class code
    TYPE 1
    Submission class code description
    Type 1 - New Molecular Entity
    Application docs
    1. ID
      87155
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220359Orig1s000lbl.pdf
      Date
      20260908
      Type
      Label
    2. ID
      87169
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220359Orig1s000ltr.pdf
      Date
      20260908
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    ETCAMAH
    Reference standard
    No
    Dosage form
    TABLET
    Route
    FILM COATED
    Marketing status
    Prescription
    Active ingredients
    1. Name
      CAMIZESTRANT
      Strength
      75MG
Harmonized identifiers (openFDA)
Application number
NDA220359
Brand name
ETCAMAH
Generic name
CAMIZESTRANT
Manufacturer name
AstraZeneca Pharmaceuticals LP
Product NDC
0310-0075
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
CAMIZESTRANT
RxCUI
2752687, 2752693
SPL ID
c54223d3-f3c7-4186-afa0-429d84805826
SPL set ID
c54223d3-f3c7-4186-afa0-429d84805826
Package NDC
0310-0075-01, 0310-0075-95
UNII
JUP57A8EPZ
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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.