Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078208
Company: ALTAIRE PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE 0.02675%;0.315% 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
09/27/2010 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/078208Orig1s000.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; 0.02675%;0.315%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE 0.02675%;0.315% SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 078208 ALTAIRE PHARMS INC
OPCON-A NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE 0.02675%;0.315% SOLUTION/DROPS;OPHTHALMIC Over-the-counter Yes 020065 BAUSCH AND LOMB

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