Approvals (Drugs@FDA)

ALCAINE

ALCON LABS INC · PROPARACAINE HYDROCHLORIDE

ANDA080027Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA080027
Sponsor name
ALCON LABS INC
Submissions
  1. Submission type
    SUPPL
    Submission number
    51
    Submission status
    AP
    Submission status date
    20240530
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    SUPPL
    Submission number
    29
    Submission status
    AP
    Submission status date
    20000811
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    SUPPL
    Submission number
    35
    Submission status
    AP
    Submission status date
    20050404
    Submission class code
    LABELING
    Submission class code description
    Labeling
  4. Submission type
    SUPPL
    Submission number
    27
    Submission status
    AP
    Submission status date
    19990421
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  5. Submission type
    SUPPL
    Submission number
    19
    Submission status
    AP
    Submission status date
    19930405
    Submission class code
    LABELING
    Submission class code description
    Labeling
  6. Submission type
    SUPPL
    Submission number
    33
    Submission status
    AP
    Submission status date
    20030806
    Submission class code
    LABELING
    Submission class code description
    Labeling
  7. Submission type
    SUPPL
    Submission number
    25
    Submission status
    AP
    Submission status date
    19990507
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  8. Submission type
    SUPPL
    Submission number
    17
    Submission status
    AP
    Submission status date
    19930604
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  9. Submission type
    SUPPL
    Submission number
    31
    Submission status
    AP
    Submission status date
    20010301
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  10. Submission type
    SUPPL
    Submission number
    23
    Submission status
    AP
    Submission status date
    20000811
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  11. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    19711222
  12. Submission type
    SUPPL
    Submission number
    15
    Submission status
    AP
    Submission status date
    19890517
    Submission class code
    LABELING
    Submission class code description
    Labeling
  13. +13 more not shown
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    ALCAINE
    Reference standard
    No
    Dosage form
    SOLUTION/DROPS
    Route
    OPHTHALMIC
    Marketing status
    Prescription
    Te code
    AT
    Active ingredients
    1. Name
      PROPARACAINE HYDROCHLORIDE
      Strength
      0.5%
Harmonized identifiers (openFDA)
Application number
ANDA080027
Brand name
PROPARACAINE HYDROCHLORIDE, ALCAINE
Generic name
PROPARACAINE HYDROCHLORIDE
Manufacturer name
Sandoz Inc., Alcon Laboratories, Inc.
Product NDC
61314-016, 0998-0016
Product type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Substance name
PROPARACAINE HYDROCHLORIDE
RxCUI
1191013, 1191026
SPL ID
ca203740-1e54-4289-9a1f-f2086fec4f46, 2060dc26-3548-4b86-900c-ef53b5f453a2
SPL set ID
447a2a64-0507-4fe8-bb44-cc36c3916151, 0c0fa0bf-977d-4539-b8dc-54c187c5b094
Package NDC
61314-016-01, 0998-0016-15
UNII
U96OL57GOY
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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.