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Details for New Drug Application (NDA): 019891
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The generic ingredient in DILAUDID 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 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, PLASTIC (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) |
Paragraph IV (Patent) Challenges for 019891
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
DILAUDID | SOLUTION;ORAL | hydromorphone hydrochloride | 019891 | 2011-02-25 |
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: | Start Trial | Patent Expiration: | Nov 9, 2020 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
Expired US Patents for NDA 019891
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Rhodes Pharms | DILAUDID | hydromorphone hydrochloride | SOLUTION;ORAL | 019891-001 | Dec 7, 1992 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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