Details for New Drug Application (NDA): 040409
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NDA 040409 describes ANEXSIA 5/325, which is a drug marketed by Specgx Llc and is included in one NDA. It is available from eight suppliers. Additional details are available on the ANEXSIA 5/325 profile page.
The generic ingredient in ANEXSIA 5/325 is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
The generic ingredient in ANEXSIA 5/325 is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for 040409
| Tradename: | ANEXSIA 5/325 |
| Applicant: | Specgx Llc |
| Ingredient: | acetaminophen; hydrocodone bitartrate |
| Patents: | 0 |
Pharmacology for NDA: 040409
| Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 040409
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ANEXSIA 5/325 | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 040409 | ANDA | SpecGx LLC | 0406-0123 | 0406-0123-01 | 100 TABLET in 1 BOTTLE (0406-0123-01) |
| ANEXSIA 5/325 | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 040409 | ANDA | SpecGx LLC | 0406-0123 | 0406-0123-05 | 500 TABLET in 1 BOTTLE (0406-0123-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;5MG | ||||
| Approval Date: | Oct 20, 2000 | TE: | AA | RLD: | No | ||||
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