Approvals (Drugs@FDA)

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE

CAPLIN · BRIMONIDINE TARTRATE, TIMOLOL MALEATE

ANDA219093Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA219093
Sponsor name
CAPLIN
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250225
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
    Reference standard
    No
    Dosage form
    SOLUTION/DROPS
    Route
    OPHTHALMIC
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      BRIMONIDINE TARTRATE
      Strength
      0.2%
    2. Name
      TIMOLOL MALEATE
      Strength
      EQ 0.5% BASE
Harmonized identifiers (openFDA)
Application number
ANDA219093
Brand name
BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION
Generic name
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
Manufacturer name
Leading Pharma, LLC, Caplin Steriles Limited
Product NDC
69315-330, 65145-162, 65145-163, 65145-164
Product type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Substance name
BRIMONIDINE TARTRATE, TIMOLOL MALEATE
RxCUI
861635
SPL ID
16b451fa-d16e-4138-a5b9-e4424e56920b, eac3cec2-b373-4936-89f0-c6d300e09f6e
SPL set ID
533f9979-0cd7-485c-8c50-abbf717c5031, eac3cec2-b373-4936-89f0-c6d300e09f6e
Package NDC
69315-330-05, 69315-330-10, 69315-330-15, 65145-162-01, 65145-163-01, 65145-164-01
UNII
4S9CL2DY2H, P8Y54F701R
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

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.