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Details for New Drug Application (NDA): 202795
The generic ingredient in NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE is naphazoline hydrochloride; pheniramine maleate. There are seven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the naphazoline hydrochloride; pheniramine maleate profile page.
Summary for 202795
Tradename: | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE |
Applicant: | Akorn Inc |
Ingredient: | naphazoline hydrochloride; pheniramine maleate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 202795
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | naphazoline hydrochloride; pheniramine maleate | SOLUTION/DROPS;OPHTHALMIC | 202795 | ANDA | Walgreens | 0363-9650 | N | 0363-9650-02 |
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | naphazoline hydrochloride; pheniramine maleate | SOLUTION/DROPS;OPHTHALMIC | 202795 | ANDA | Akorn, Inc. | 17478-065 | N | 17478-065-12 |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.025%;0.3% | ||||
Approval Date: | Jan 24, 2013 | TE: | RLD: | No |
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