Approvals (Drugs@FDA)

LOFEXIDINE HYDROCHLORIDE

MSN · LOFEXIDINE HYDROCHLORIDE

ANDA218699Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA218699
Sponsor name
MSN
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250224
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    LOFEXIDINE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      LOFEXIDINE HYDROCHLORIDE
      Strength
      EQ 0.18MG BASE
Harmonized identifiers (openFDA)
Application number
ANDA218699
Brand name
LOFEXIDINE HYDROCHLORIDE
Generic name
LOFEXIDINE HYDROCHLORIDE
Manufacturer name
Novadoz Pharmaceuticals LLC
Product NDC
72205-246
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
LOFEXIDINE HYDROCHLORIDE
RxCUI
2046591
SPL ID
19b5c932-af2d-4a0b-ac4a-ba06c53c3219
SPL set ID
19b5c932-af2d-4a0b-ac4a-ba06c53c3219
Package NDC
72205-246-42, 72205-246-43
UNII
V47G1SDI1B
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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.