Approvals (Drugs@FDA)

TESTOSTERONE

TWI PHARMS · TESTOSTERONE

ANDA209390Generic (ANDA)Discontinued
Open FDA's page for this record
Application number
ANDA209390
Sponsor name
TWI PHARMS
Submissions
  1. Submission type
    SUPPL
    Submission number
    11
    Submission status
    AP
    Submission status date
    20260915
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20190923
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    TESTOSTERONE
    Reference standard
    No
    Dosage form
    GEL, METERED
    Route
    TRANSDERMAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      TESTOSTERONE
      Strength
      1.62% (20.25MG/1.25GM ACTUATION)
Harmonized identifiers (openFDA)
Application number
ANDA209390
Brand name
TESTOSTERONE
Generic name
TESTOSTERONE
Manufacturer name
Upsher-Smith Laboratories, LLC
Product NDC
24979-078
Product type
HUMAN PRESCRIPTION DRUG
Route
TRANSDERMAL
Substance name
TESTOSTERONE
RxCUI
1597076
SPL ID
183542a9-eb31-4328-9c28-17264a898d03
SPL set ID
10dab294-6a43-4bb3-9d91-2d200c624ffb
Package NDC
24979-078-15
Nui
N0000175824, N0000000146, M0001109
Pharm class epc
Androgen [EPC]
Pharm class moa
Androgen Receptor Agonists [MoA]
Pharm class cs
Androstanes [CS]
UNII
3XMK78S47O
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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.