Approvals (Drugs@FDA)

ESOMEPRAZOLE MAGNESIUM

TORRENT · ESOMEPRAZOLE MAGNESIUM

ANDA212651Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA212651
Sponsor name
TORRENT
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250305
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    004
    Reference drug
    No
    Brand name
    ESOMEPRAZOLE MAGNESIUM
    Reference standard
    No
    Dosage form
    FOR SUSPENSION, DELAYED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ESOMEPRAZOLE MAGNESIUM
      Strength
      EQ 40MG BASE/PACKET
  2. Product number
    002
    Reference drug
    No
    Brand name
    ESOMEPRAZOLE MAGNESIUM
    Reference standard
    No
    Dosage form
    FOR SUSPENSION, DELAYED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ESOMEPRAZOLE MAGNESIUM
      Strength
      EQ 5MG BASE/PACKET
  3. Product number
    003
    Reference drug
    No
    Brand name
    ESOMEPRAZOLE MAGNESIUM
    Reference standard
    No
    Dosage form
    FOR SUSPENSION, DELAYED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ESOMEPRAZOLE MAGNESIUM
      Strength
      EQ 20MG BASE/PACKET
  4. Product number
    001
    Reference drug
    No
    Brand name
    ESOMEPRAZOLE MAGNESIUM
    Reference standard
    No
    Dosage form
    FOR SUSPENSION, DELAYED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ESOMEPRAZOLE MAGNESIUM
      Strength
      EQ 2.5MG BASE/PACKET
Harmonized identifiers (openFDA)
Application number
ANDA212651
Brand name
ESOMEPRAZOLE MAGNESIUM FOR DELAYED-RELEASE ORAL SUSPENSION
Generic name
ESOMEPRAZOLE MAGNESIUM
Manufacturer name
Torrent Pharmaceuticals Limited
Product NDC
13668-546, 13668-547, 13668-549, 13668-550
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
ESOMEPRAZOLE MAGNESIUM
RxCUI
692576, 692578, 1297658, 1297761
SPL ID
3e6da063-fd01-4d9f-8b56-5e7cf3e15223
SPL set ID
992b1830-55cc-4e95-8d6d-e7f796d5b373
Package NDC
13668-546-94, 13668-547-94, 13668-549-94, 13668-550-94
UNII
R6DXU4WAY9
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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.