Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202795
Company: AKORN INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE 0.025%;0.3% SOLUTION/DROPS;OPHTHALMIC Over-the-counter None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/24/2013 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202795Orig1s000ltr.pdf

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SOLUTION/DROPS;OPHTHALMIC; 0.025%;0.3%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE 0.025%;0.3% SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 202795 AKORN INC
NAPHCON-A NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE 0.025%;0.3% SOLUTION/DROPS;OPHTHALMIC Over-the-counter Yes 020226 ALCON
VISINE NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE 0.025%;0.3% SOLUTION/DROPS;OPHTHALMIC Over-the-counter Yes 020485 JOHNSON AND JOHNSON

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