Details for New Drug Application (NDA): 205629
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NDA 205629 describes HYDROMORPHONE HYDROCHLORIDE, which is a drug marketed by Barr, Hikma, Hospira, Hospira Inc, Rising, Watson Labs, Ascent Pharms Inc, Genus, 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 twelve 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. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 205629
| Tradename: | HYDROMORPHONE HYDROCHLORIDE |
| Applicant: | Osmotica Pharm Us |
| Ingredient: | hydromorphone hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205629
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 205629
Suppliers and Packaging for NDA: 205629
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205629 | ANDA | Trigen Laboratories, LLC | 13811-701 | 13811-701-10 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-701-10) |
| HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205629 | ANDA | Trigen Laboratories, LLC | 13811-702 | 13811-702-10 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-702-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 8MG | ||||
| Approval Date: | Jul 7, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 12MG | ||||
| Approval Date: | Jul 7, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 16MG | ||||
| Approval Date: | Jul 7, 2016 | TE: | AB | RLD: | No | ||||
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