Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202795
Company: RISING PHARMA
Company: RISING PHARMA
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 | RISING PHARMA |
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 |