Details for New Drug Application (NDA): 201384
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NDA 201384 describes TRAMADOL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma Ltd, Endo Operations, Lupin Ltd, Mylan, Strides Pharma, Sun Pharm, Accord Hlthcare, ACI, Amneal Pharms, Apotex, Asta, Cspc Ouyi Pharm Co, Graviti Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Merro Pharm Usa, Mylan Pharms Inc, Northstar Hlthcare, Pliva, Rubicon, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Unichem, Watson Labs, Zydus Pharms Usa Inc, Alkem Labs Ltd, Aurobindo Pharma, Chartwell Rx, Micro Labs Ltd India, Nostrum Labs Inc, and Rising, and is included in forty-four NDAs. It is available from forty-three 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. Seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.
Summary for 201384
| Tradename: | TRAMADOL HYDROCHLORIDE |
| Applicant: | Sun Pharm |
| Ingredient: | tramadol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 201384
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 201384
Suppliers and Packaging for NDA: 201384
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201384 | ANDA | Lake Erie Medical DBA Quality Care Products LLC | 35356-790 | 35356-790-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-790-30) |
| TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201384 | ANDA | medsource pharmaceuticals | 45865-876 | 45865-876-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-876-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Dec 7, 2011 | TE: | AB1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 200MG | ||||
| Approval Date: | Dec 7, 2011 | TE: | AB1 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | Dec 7, 2011 | TE: | AB1 | RLD: | No | ||||
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