Details for New Drug Application (NDA): 019034
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NDA 019034 describes DILAUDID-HP, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DILAUDID-HP profile page.
The generic ingredient in DILAUDID-HP 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.
The generic ingredient in DILAUDID-HP 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 019034
| Tradename: | DILAUDID-HP |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | hydromorphone hydrochloride |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 019034
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 019034
Suppliers and Packaging for NDA: 019034
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DILAUDID | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034 | NDA | Fresenius Kabi USA, LLC | 63323-851 | 63323-851-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-851-10) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-851-03) |
| DILAUDID | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034 | NDA | Fresenius Kabi USA, LLC | 63323-851 | 63323-851-15 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-851-15) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-851-07) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Jan 11, 1984 | TE: | RLD: | Yes | |||||
| Patent: | See Plans and Pricing | Patent Expiration: | Mar 12, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | See Plans and Pricing | Patent Expiration: | Apr 23, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 250MG/VIAL | ||||
| Approval Date: | Aug 4, 1994 | TE: | RLD: | No | |||||
| Patent: | See Plans and Pricing | Patent Expiration: | Mar 12, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 019034
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | DILAUDID | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-003 | Apr 30, 2009 | See Plans and Pricing | See Plans and Pricing |
| Fresenius Kabi Usa | DILAUDID | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-005 | Apr 30, 2009 | See Plans and Pricing | See Plans and Pricing |
| Fresenius Kabi Usa | DILAUDID-HP | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-001 | Jan 11, 1984 | See Plans and Pricing | See Plans and Pricing |
| Fresenius Kabi Usa | DILAUDID-HP | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-002 | Aug 4, 1994 | See Plans and Pricing | See Plans and Pricing |
| Fresenius Kabi Usa | DILAUDID | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-004 | Apr 30, 2009 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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