Details for New Drug Application (NDA): 090585
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NDA 090585 describes ORPHENADRINE CITRATE, which is a drug marketed by Hikma, Rising, Sagent Pharms, Watson Labs, Ascot, Bayshore Pharms Llc, Lupin, Sandoz, and Stevens J, and is included in fifteen NDAs. It is available from twenty suppliers. Additional details are available on the ORPHENADRINE CITRATE profile page.
The generic ingredient in ORPHENADRINE CITRATE is aspirin; caffeine; orphenadrine citrate. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aspirin; caffeine; orphenadrine citrate profile page.
The generic ingredient in ORPHENADRINE CITRATE is aspirin; caffeine; orphenadrine citrate. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aspirin; caffeine; orphenadrine citrate profile page.
Summary for 090585
| Tradename: | ORPHENADRINE CITRATE |
| Applicant: | Sagent Pharms |
| Ingredient: | orphenadrine citrate |
| Patents: | 0 |
Pharmacology for NDA: 090585
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Suppliers and Packaging for NDA: 090585
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ORPHENADRINE CITRATE | orphenadrine citrate | INJECTABLE;INJECTION | 090585 | ANDA | Sagent Pharmaceuticals | 25021-651 | 25021-651-02 | 10 VIAL in 1 CARTON (25021-651-02) / 2 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 30MG/ML | ||||
| Approval Date: | Aug 30, 2011 | TE: | AP | RLD: | No | ||||
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