Approvals (Drugs@FDA)

ESTRADIOL

ENCUBE · ESTRADIOL

ANDA218507Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA218507
Sponsor name
ENCUBE
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250305
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  2. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260819
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    005
    Reference drug
    No
    Brand name
    ESTRADIOL
    Reference standard
    No
    Dosage form
    GEL
    Route
    TRANSDERMAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ESTRADIOL
      Strength
      0.1% (1.25GM/PACKET)
  2. Product number
    003
    Reference drug
    No
    Brand name
    ESTRADIOL
    Reference standard
    No
    Dosage form
    GEL
    Route
    TRANSDERMAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ESTRADIOL
      Strength
      0.1% (0.75GM/PACKET)
  3. Product number
    001
    Reference drug
    No
    Brand name
    ESTRADIOL
    Reference standard
    No
    Dosage form
    GEL
    Route
    TRANSDERMAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ESTRADIOL
      Strength
      0.1% (0.25GM/PACKET)
  4. Product number
    004
    Reference drug
    No
    Brand name
    ESTRADIOL
    Reference standard
    No
    Dosage form
    GEL
    Route
    TRANSDERMAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ESTRADIOL
      Strength
      0.1% (1GM/PACKET)
  5. Product number
    002
    Reference drug
    No
    Brand name
    ESTRADIOL
    Reference standard
    No
    Dosage form
    GEL
    Route
    TRANSDERMAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ESTRADIOL
      Strength
      0.1% (0.5GM/PACKET)
Harmonized identifiers (openFDA)
Application number
ANDA218507
Brand name
ESTRADIOL GEL
Generic name
ESTRADIOL
Manufacturer name
Encube Ethicals, Inc.
Product NDC
21922-086, 21922-087, 21922-088, 21922-089, 21922-090
Product type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Substance name
ESTRADIOL
RxCUI
2619677, 2619679, 2619681, 2619683, 2619685
SPL ID
5390c5ff-21e0-4b69-9e88-5593dbcbd9fe
SPL set ID
d4a3606f-83b2-45df-bc77-faebfa796f9a
Package NDC
21922-086-52, 21922-087-52, 21922-088-52, 21922-089-52, 21922-090-52
Nui
M0447348, N0000175825, N0000000100
Pharm class cs
Estradiol Congeners [CS]
Pharm class epc
Estrogen [EPC]
Pharm class moa
Estrogen Receptor Agonists [MoA]
UNII
4TI98Z838E
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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.