Approvals (Drugs@FDA)

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE

GLENMARK PHARMS LTD · BRIMONIDINE TARTRATE, TIMOLOL MALEATE

ANDA214987Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA214987
Sponsor name
GLENMARK PHARMS LTD
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240516
    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
ANDA214987
Brand name
BRIMONIDINE TARTRATE/TIMOLOL MALEATE
Generic name
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
Manufacturer name
Glenmark Pharmaceuticals Inc., USA
Product NDC
68462-281
Product type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Substance name
BRIMONIDINE TARTRATE, TIMOLOL MALEATE
RxCUI
861635
SPL ID
e97c8703-5166-49b6-8dd2-69c5b9dfcae8
SPL set ID
bf6a7f59-5a10-49fe-9e57-19e3ba202918
Package NDC
68462-281-69, 68462-281-32
UNII
4S9CL2DY2H, P8Y54F701R
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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.