Details for New Drug Application (NDA): 216899
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NDA 216899 describes HYDROMORPHONE HYDROCHLORIDE, which is a drug marketed by Barr, Hikma, Hospira, Hospira Inc, Rising, Watson Labs, Ascent Pharms Inc, Chartwell, Actavis Labs Fl Inc, Osmotica Pharm Us, Padagis Us, Aurolife Pharma Llc, Nesher Pharms, Nostrum Labs Inc, and Specgx Llc, and is included in twenty-four NDAs. It is available from fifteen suppliers. Additional details are available on the HYDROMORPHONE HYDROCHLORIDE profile page.
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.
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 216899
| Tradename: | HYDROMORPHONE HYDROCHLORIDE |
| Applicant: | Hikma |
| Ingredient: | hydromorphone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 216899
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 216899
Suppliers and Packaging for NDA: 216899
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | INJECTABLE;INJECTION | 216899 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6169 | 0641-6169-10 | 10 SYRINGE in 1 CARTON (0641-6169-10) / 1 mL in 1 SYRINGE (0641-6169-01) |
| HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | INJECTABLE;INJECTION | 216899 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6170 | 0641-6170-10 | 10 SYRINGE in 1 CARTON (0641-6170-10) / 1 mL in 1 SYRINGE (0641-6170-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.2MG/ML | ||||
| Approval Date: | Feb 9, 2024 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5MG/0.5ML | ||||
| Approval Date: | Feb 9, 2024 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 11, 2024 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Feb 9, 2024 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Dec 2, 2024 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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