Details for New Drug Application (NDA): 078208
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NDA 078208 describes NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, which is a drug marketed by Altaire Pharms Inc and Rising and is included in two NDAs. It is available from one supplier. 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 eight drug master file entries for this compound. Eleven 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 eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the naphazoline hydrochloride; pheniramine maleate profile page.
Summary for 078208
| Tradename: | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE |
| Applicant: | Altaire Pharms Inc |
| Ingredient: | naphazoline hydrochloride; pheniramine maleate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078208
| 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 | 078208 | ANDA | Altaire Pharmaceuticals Inc. | 59390-177 | 59390-177-13 | 15 mL in 1 BOTTLE, DROPPER (59390-177-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.02675%;0.315% | ||||
| Approval Date: | Sep 27, 2010 | TE: | RLD: | No | |||||
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