Approvals (Drugs@FDA)

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

PHARMAZONE · NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

ANDA220269Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA220269
Sponsor name
PHARMAZONE
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260407
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      NITROFURANTOIN
      Strength
      75MG
    2. Name
      NITROFURANTOIN, MACROCRYSTALLINE
      Strength
      25MG
Harmonized identifiers (openFDA)
Application number
ANDA220269
Brand name
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Generic name
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Manufacturer name
Creekwood Pharmaceuticals LLC
Product NDC
82619-147
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
NITROFURANTOIN, NITROFURANTOIN MONOHYDRATE
RxCUI
1648755
SPL ID
4f67eeb9-5a7a-3693-e063-6394a90a8655
SPL set ID
e47175a3-68a2-4084-9c0e-96fb057448bf
Package NDC
82619-147-01, 82619-147-03, 82619-147-02
Nui
N0000175494, M0014892
Pharm class epc
Nitrofuran Antibacterial [EPC]
Pharm class cs
Nitrofurans [CS]
UNII
927AH8112L, E1QI2CQQ1I
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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.