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Details for New Drug Application (NDA): 019891
NDA 019891 describes DILAUDID, which is a drug marketed by Fresenius Kabi Usa and Rhodes Pharms and is included in three NDAs. It is available from four suppliers. There are three patents protecting this drug and four Paragraph IV challenges. Additional details are available on the DILAUDID profile page.
The generic ingredient in DILAUDID is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
The generic ingredient in DILAUDID is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 019891
| Tradename: | DILAUDID |
| Applicant: | Rhodes Pharms |
| Ingredient: | hydromorphone hydrochloride |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 019891
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 019891
Suppliers and Packaging for NDA: 019891
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DILAUDID | hydromorphone hydrochloride | SOLUTION;ORAL | 019891 | NDA AUTHORIZED GENERIC | Rhodes Pharmaceuticals L.P. | 42858-304 | 42858-304-16 | 473 mL in 1 BOTTLE, GLASS (42858-304-16) |
| DILAUDID | hydromorphone hydrochloride | SOLUTION;ORAL | 019891 | NDA | Rhodes Pharmaceuticals L.P. | 42858-416 | 42858-416-16 | 473 mL in 1 BOTTLE, PLASTIC (42858-416-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
| Approval Date: | Dec 7, 1992 | TE: | AA | RLD: | Yes | ||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Nov 9, 2020 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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