Details for New Drug Application (NDA): 205814
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The generic ingredient in HYDROMORPHONE HYDROCHLORIDE is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 205814
Tradename: | HYDROMORPHONE HYDROCHLORIDE |
Applicant: | Aurolife Pharma Llc |
Ingredient: | hydromorphone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205814
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 205814
Suppliers and Packaging for NDA: 205814
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | TABLET;ORAL | 205814 | ANDA | Aurolife Pharma, LLC | 13107-107 | 13107-107-01 | 100 TABLET in 1 BOTTLE (13107-107-01) |
HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | TABLET;ORAL | 205814 | ANDA | Aurolife Pharma, LLC | 13107-107 | 13107-107-05 | 500 TABLET in 1 BOTTLE (13107-107-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | May 13, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
Approval Date: | May 13, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
Approval Date: | May 13, 2016 | TE: | AB | RLD: | No |
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