Approvals (Drugs@FDA)

LANREOTIDE ACETATE

INVAGEN PHARMS · LANREOTIDE ACETATE

ANDA217193Generic (ANDA)Discontinued
Open FDA's page for this record
Application number
ANDA217193
Sponsor name
INVAGEN PHARMS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240521
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      78843
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217193Orig1s000ltr.pdf
      Date
      20240620
      Type
      Letter
  2. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20261026
    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
    20261026
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    003
    Reference drug
    No
    Brand name
    LANREOTIDE ACETATE
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      LANREOTIDE ACETATE
      Strength
      EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)
  2. Product number
    001
    Reference drug
    No
    Brand name
    LANREOTIDE ACETATE
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      LANREOTIDE ACETATE
      Strength
      EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)
  3. Product number
    002
    Reference drug
    No
    Brand name
    LANREOTIDE ACETATE
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      LANREOTIDE ACETATE
      Strength
      EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)
Harmonized identifiers (openFDA)
Application number
ANDA217193
Brand name
LANREOTIDE ACETATE
Generic name
LANREOTIDE ACETATE
Manufacturer name
Cipla USA Inc., EXELAN PHARMACEUTICALS, INC.
Product NDC
69097-906, 69097-907, 69097-908, 76282-718, 76282-719, 76282-720
Product type
HUMAN PRESCRIPTION DRUG
Route
SUBCUTANEOUS
Substance name
LANREOTIDE ACETATE
RxCUI
749811, 749814, 749817
SPL ID
6d47aa22-362a-4663-8b98-a16c4ff0607a, 054af266-c850-45c8-b027-d810d7d5f0ae
SPL set ID
2892b4c3-0329-4d29-97ff-3b45283bbab1, eec3c37e-83a7-4195-bccf-cd5973459eef
Package NDC
69097-907-67, 69097-908-67, 69097-906-67, 76282-718-67, 76282-719-67, 76282-720-67
UNII
IEU56G3J9C
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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.