Approvals (Drugs@FDA)

BROMFENAC SODIUM

LUPIN · BROMFENAC SODIUM

ANDA211239Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA211239
Sponsor name
LUPIN
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240202
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      77739
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211239Orig1s000ltr.pdf
      Date
      20240307
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    BROMFENAC SODIUM
    Reference standard
    No
    Dosage form
    SOLUTION/DROPS
    Route
    OPHTHALMIC
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      BROMFENAC SODIUM
      Strength
      EQ 0.075% ACID
Harmonized identifiers (openFDA)
Application number
ANDA211239
Brand name
BROMFENAC
Generic name
BROMFENAC
Manufacturer name
Lupin Pharmaceuticals, Inc.
Product NDC
68180-434
Product type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Substance name
BROMFENAC SODIUM
RxCUI
1790141
SPL ID
bde2565a-075e-4910-874b-9737d0ed9ccc
SPL set ID
2b2621e7-a69e-4286-a7e7-0fc31a91fe29
Package NDC
68180-434-01
UNII
8ECV571Y37
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.