DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 076855
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 |
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