Details for New Drug Application (NDA): 210176
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The generic ingredient in HYDROMORPHONE HYDROCHLORIDE is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 210176
Tradename: | HYDROMORPHONE HYDROCHLORIDE |
Applicant: | Ascent Pharms Inc |
Ingredient: | hydromorphone hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 210176
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 210176
Suppliers and Packaging for NDA: 210176
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | SOLUTION;ORAL | 210176 | ANDA | Ascent Pharmaceuticals Inc | 43602-001 | 43602-001-47 | 473 mL in 1 BOTTLE (43602-001-47) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Oct 27, 2017 | TE: | AA | RLD: | No |
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