Approvals (Drugs@FDA)

ERLOTINIB HYDROCHLORIDE

HETERO LABS LTD V · ERLOTINIB HYDROCHLORIDE

ANDA209267Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA209267
Sponsor name
HETERO LABS LTD V
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240524
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    ERLOTINIB HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ERLOTINIB HYDROCHLORIDE
      Strength
      EQ 100MG BASE
  2. Product number
    003
    Reference drug
    No
    Brand name
    ERLOTINIB HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ERLOTINIB HYDROCHLORIDE
      Strength
      EQ 150MG BASE
  3. Product number
    001
    Reference drug
    No
    Brand name
    ERLOTINIB HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ERLOTINIB HYDROCHLORIDE
      Strength
      EQ 25MG BASE
Harmonized identifiers (openFDA)
Application number
ANDA209267
Brand name
ERLOTINIB
Generic name
ERLOTINIB
Manufacturer name
Camber Pharmaceuticals, Inc.
Product NDC
31722-263, 31722-264, 31722-265
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
ERLOTINIB HYDROCHLORIDE
RxCUI
603203, 603206, 603208
SPL ID
1bca3db4-f885-5bed-e063-6294a90ae9fa
SPL set ID
a3b2d622-b4d5-4819-862b-f8fd3adcec6f
Package NDC
31722-263-30, 31722-264-30, 31722-265-30
UNII
DA87705X9K
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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.