Approvals (Drugs@FDA)

METHSCOPOLAMINE BROMIDE

NE RX PHARMA · METHSCOPOLAMINE BROMIDE

ANDA216786Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA216786
Sponsor name
NE RX PHARMA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240201
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    METHSCOPOLAMINE BROMIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AA
    Active ingredients
    1. Name
      METHSCOPOLAMINE BROMIDE
      Strength
      5MG
  2. Product number
    001
    Reference drug
    No
    Brand name
    METHSCOPOLAMINE BROMIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AA
    Active ingredients
    1. Name
      METHSCOPOLAMINE BROMIDE
      Strength
      2.5MG
Harmonized identifiers (openFDA)
Application number
ANDA216786
Brand name
METHSCOPOLAMINE BROMIDE
Generic name
METHSCOPOLAMINE BROMIDE
Manufacturer name
i3 Pharmaceuticals, LLC
Product NDC
72319-029, 72319-030
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
METHSCOPOLAMINE BROMIDE
RxCUI
314088, 403914
SPL ID
2ee941f2-7d8c-dd6e-e063-6394a90a0db9
SPL set ID
14c0c030-e96d-4a5e-95ff-02dd78a46be3
Package NDC
72319-029-04, 72319-029-06, 72319-030-02, 72319-030-06
UNII
RTN51LK7WL
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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.