Details for New Drug Application (NDA): 040284
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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 040284
Tradename: | ORPHENADRINE CITRATE |
Applicant: | Lupin |
Ingredient: | orphenadrine citrate |
Patents: | 0 |
Pharmacology for NDA: 040284
Physiological Effect | Centrally-mediated Muscle Relaxation |
Suppliers and Packaging for NDA: 040284
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ORPHENADRINE CITRATE | orphenadrine citrate | TABLET, EXTENDED RELEASE;ORAL | 040284 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-407 | 43063-407-14 | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-14) |
ORPHENADRINE CITRATE | orphenadrine citrate | TABLET, EXTENDED RELEASE;ORAL | 040284 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-407 | 43063-407-20 | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | Jun 19, 1998 | TE: | AB | RLD: | No |
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