Details for New Drug Application (NDA): 205479
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NDA 205479 describes HYDROCODONE BITARTRATE AND ASPIRIN, which is a drug marketed by Lgm Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the HYDROCODONE BITARTRATE AND ASPIRIN profile page.
The generic ingredient in HYDROCODONE BITARTRATE AND ASPIRIN is aspirin; hydrocodone bitartrate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aspirin; hydrocodone bitartrate profile page.
The generic ingredient in HYDROCODONE BITARTRATE AND ASPIRIN is aspirin; hydrocodone bitartrate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aspirin; hydrocodone bitartrate profile page.
Summary for 205479
| Tradename: | HYDROCODONE BITARTRATE AND ASPIRIN |
| Applicant: | Lgm Pharma |
| Ingredient: | aspirin; hydrocodone bitartrate |
| Patents: | 0 |
Pharmacology for NDA: 205479
| Mechanism of Action | Cyclooxygenase Inhibitors Opioid Agonists |
| Physiological Effect | Decreased Platelet Aggregation Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 205479
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ASPIRIN | aspirin; hydrocodone bitartrate | TABLET;ORAL | 205479 | ANDA | LGM PHARMA SOLUTIONS, LLC | 79739-7182 | 79739-7182-1 | 100 TABLET in 1 BOTTLE (79739-7182-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG;5MG | ||||
| Approval Date: | May 28, 2021 | TE: | RLD: | No | |||||
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