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Details for New Drug Application (NDA): 202795
NDA 202795 describes NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, which is a drug marketed by Akorn Inc and Altaire Pharms Inc and is included in two NDAs. It is available from six suppliers. Additional details are available on the NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE profile page.
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.
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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