Details for New Drug Application (NDA): 090460
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NDA 090460 describes TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Graviti Pharms, Macleods Pharms Ltd, Micro Labs Ltd India, Nostrum Labs Inc, Rising, Sun Pharm Inds Inc, and Zydus Pharms Usa Inc, and is included in eleven NDAs. It is available from seventeen suppliers. Additional details are available on the TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN profile page.
The generic ingredient in TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN is acetaminophen; tramadol hydrochloride. There are sixty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.
The generic ingredient in TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN is acetaminophen; tramadol hydrochloride. There are sixty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.
Summary for 090460
| Tradename: | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN |
| Applicant: | Zydus Pharms Usa Inc |
| Ingredient: | acetaminophen; tramadol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 090460
| Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 090460
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | acetaminophen; tramadol hydrochloride | TABLET;ORAL | 090460 | ANDA | St. Mary's Medical Park Pharmacy | 60760-335 | 60760-335-20 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-335-20) |
| TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | acetaminophen; tramadol hydrochloride | TABLET;ORAL | 090460 | ANDA | Proficient Rx LP | 63187-585 | 63187-585-30 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-585-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;37.5MG | ||||
| Approval Date: | Sep 6, 2012 | TE: | AB | RLD: | No | ||||
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