DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 078783
NDA 078783 describes TRAMADOL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Anchen Pharms, Aurobindo Pharma Ltd, Lupin Ltd, Mylan Pharms Inc, Par Pharm Inc, Sun Pharma Global, Accord Hlthcare, Aci Healthcare Ltd, Amneal Pharms, Apotex, Asta, Cspc Ouyi Pharm Co, Fosun Pharma, Ipca Labs Ltd, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Mylan, Northstar Hlthcare, Pliva, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Watson Labs, Zydus Pharms Usa Inc, Alkem Labs Ltd, Apotex Inc, Cspc Ouyi, Micro Labs Ltd India, and Par Pharm, and is included in forty-one NDAs. It is available from fifty-seven suppliers. Additional details are available on the TRAMADOL HYDROCHLORIDE profile page.
The generic ingredient in TRAMADOL HYDROCHLORIDE is acetaminophen; tramadol hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.
The generic ingredient in TRAMADOL HYDROCHLORIDE is acetaminophen; tramadol hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.
Summary for 078783
| Tradename: | TRAMADOL HYDROCHLORIDE |
| Applicant: | Par Pharm Inc |
| Ingredient: | tramadol hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078783
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 078783
Suppliers and Packaging for NDA: 078783
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 078783 | ANDA | Rebel Distributors Corp. | 21695-699 | 21695-699-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (21695-699-30) |
| TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 078783 | ANDA | Rebel Distributors Corp. | 21695-700 | 21695-700-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (21695-700-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Nov 13, 2009 | TE: | AB1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 200MG | ||||
| Approval Date: | Nov 13, 2009 | TE: | AB1 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | Sep 20, 2011 | TE: | AB1 | RLD: | No | ||||
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