DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 076855
NDA 076855 describes HYDROMORPHONE HYDROCHLORIDE, which is a drug marketed by Akorn, Barr, Hospira, Hospira Inc, Watson Labs, Ascent Pharms Inc, West-ward Pharms Int, Actavis Labs Fl Inc, Osmotica, Paddock Llc, Aurolife Pharma Llc, Elite Labs, Lannett, Nesher Pharms, and Specgx Llc, and is included in twenty NDAs. It is available from twenty-one suppliers. Additional details are available on the HYDROMORPHONE HYDROCHLORIDE profile page.
The generic ingredient in HYDROMORPHONE HYDROCHLORIDE is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
The generic ingredient in HYDROMORPHONE HYDROCHLORIDE is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 076855
| Tradename: | HYDROMORPHONE HYDROCHLORIDE |
| Applicant: | Specgx Llc |
| Ingredient: | hydromorphone hydrochloride |
| Patents: | 0 |
| Therapeutic Class: | Analgesics |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076855
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 076855
Suppliers and Packaging for NDA: 076855
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | TABLET;ORAL | 076855 | ANDA | SpecGx LLC | 0406-3243 | N | 0406-3243-01 |
| HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | TABLET;ORAL | 076855 | ANDA | SpecGx LLC | 0406-3244 | N | 0406-3244-01 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
| Approval Date: | Dec 23, 2004 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Sep 19, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
| Approval Date: | Sep 19, 2007 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
