Details for New Drug Application (NDA): 040327
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NDA 040327 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the aspirin; caffeine; orphenadrine citrate profile page.
Summary for 040327
| Tradename: | ORPHENADRINE CITRATE |
| Applicant: | Sandoz |
| Ingredient: | orphenadrine citrate |
| Patents: | 0 |
Pharmacology for NDA: 040327
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Suppliers and Packaging for NDA: 040327
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ORPHENADRINE CITRATE | orphenadrine citrate | TABLET, EXTENDED RELEASE;ORAL | 040327 | ANDA | Sandoz Inc | 0185-0022 | 0185-0022-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0022-01) |
| ORPHENADRINE CITRATE | orphenadrine citrate | TABLET, EXTENDED RELEASE;ORAL | 040327 | ANDA | Proficient Rx LP | 63187-632 | 63187-632-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-632-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Feb 15, 2000 | TE: | AB | RLD: | No | ||||
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