Approvals (Drugs@FDA)

NICARDIPINE HYDROCHLORIDE

MANKIND PHARMA · NICARDIPINE HYDROCHLORIDE

ANDA090671Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA090671
Sponsor name
MANKIND PHARMA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20091117
  2. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20250509
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20230206
    Review priority
    UNKNOWN
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    NICARDIPINE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      NICARDIPINE HYDROCHLORIDE
      Strength
      25MG/10ML (2.5MG/ML)
Harmonized identifiers (openFDA)
Application number
ANDA090671
Brand name
NICARDIPINE HYDROCHLORIDE
Generic name
NICARDIPINE HYDROCHLORIDE
Manufacturer name
Lifestar Pharma LLC
Product NDC
70756-686
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Substance name
NICARDIPINE HYDROCHLORIDE
RxCUI
858607
SPL ID
81fbc156-3cdc-4088-84fd-2d2bf30ebc66
SPL set ID
b0e2bed3-f928-43ab-a05c-275bedc9856f
Package NDC
70756-686-86, 70756-686-10
UNII
K5BC5011K3
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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.