Details for New Drug Application (NDA): 013055
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NDA 013055 describes NORFLEX, which is a drug marketed by Pai Holdings Pharm and Bausch and is included in two NDAs. Additional details are available on the NORFLEX profile page.
The generic ingredient in NORFLEX is orphenadrine citrate. There are nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the orphenadrine citrate profile page.
The generic ingredient in NORFLEX is orphenadrine citrate. There are nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the orphenadrine citrate profile page.
Summary for 013055
| Tradename: | NORFLEX |
| Applicant: | Pai Holdings Pharm |
| Ingredient: | orphenadrine citrate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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