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Details for New Drug Application (NDA): 078783
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NDA 078783 describes TRAMADOL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Anchen Pharms, Aurobindo Pharma Ltd, Lupin Ltd, Mylan, Par Pharm Inc, Sun Pharm, 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 Pharms Inc, Northstar Hlthcare, Pliva, Polygen Pharms, Rubicon, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Unichem Labs Ltd, 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-four NDAs. It is available from forty-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. Twenty-seven 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. Twenty-seven 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 |
Medical Subject Heading (MeSH) Categories for 078783
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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