Approvals (Drugs@FDA)

LIDOCAINE HYDROCHLORIDE

ANTHEA PHARMA · LIDOCAINE HYDROCHLORIDE

ANDA219535Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA219535
Sponsor name
ANTHEA PHARMA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250402
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  2. Submission type
    SUPPL
    Submission number
    7
    Submission status
    AP
    Submission status date
    20251002
    Review priority
    UNKNOWN
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    LIDOCAINE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      LIDOCAINE HYDROCHLORIDE
      Strength
      1%
  2. Product number
    002
    Reference drug
    No
    Brand name
    LIDOCAINE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      LIDOCAINE HYDROCHLORIDE
      Strength
      2%
Harmonized identifiers (openFDA)
Application number
ANDA219535
Brand name
LIDOCAINE HYDROCHLORIDE
Generic name
LIDOCAINE HYDROCHLORIDE
Manufacturer name
Anthea Pharma Private Limited, Avenacy, LLC
Product NDC
83854-009, 83854-011, 83854-012, 83854-010, 83634-651, 83634-653
Product type
HUMAN PRESCRIPTION DRUG
Route
INFILTRATION, PERINEURAL, EPIDURAL, INTRACAUDAL
Substance name
LIDOCAINE HYDROCHLORIDE
RxCUI
1010033, 1010671, 1737562, 1737566, 1737568, 1737757, 1737761
SPL ID
4a996c97-9beb-712a-e063-6294a90a1994, 8fb1dd7b-f349-4a64-96c1-bd72bf748f3b
SPL set ID
240c4744-e58c-4c08-93ad-8d6418c4f8a9, 46480253-29b9-4d7f-98ed-10377929026b
Package NDC
83854-009-01, 83854-009-25, 83854-009-02, 83854-009-26, 83854-009-03, 83854-009-27, 83854-011-01, 83854-011-25, 83854-011-02, 83854-011-26, 83854-011-03, 83854-011-27, 83854-012-01, 83854-012-25, 83854-012-02, 83854-012-26, 83854-010-01, 83854-010-25, 83854-010-02, 83854-010-26, 83854-010-03, 83854-010-27, 83634-653-41, 83634-653-02, 83634-653-42, 83634-653-05, 83634-653-43, 83634-653-30, 83634-651-41, 83634-651-10, 83634-651-42, 83634-651-20, 83634-651-43, 83634-651-50
UNII
V13007Z41A
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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.