Details for New Drug Application (NDA): 202144
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NDA 202144 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 202144
| Tradename: | HYDROMORPHONE HYDROCHLORIDE |
| Applicant: | Actavis Labs Fl Inc |
| Ingredient: | hydromorphone hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 202144
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 8MG | ||||
| Approval Date: | May 12, 2014 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 12MG | ||||
| Approval Date: | May 12, 2014 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 16MG | ||||
| Approval Date: | May 12, 2014 | TE: | RLD: | No | |||||
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