Details for New Drug Application (NDA): 212133
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NDA 212133 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, Mpp Pharma, Nesher Pharms, and Specgx Llc, and is included in twenty-four NDAs. It is available from fourteen 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 212133
| Tradename: | HYDROMORPHONE HYDROCHLORIDE |
| Applicant: | Ascent Pharms Inc |
| Ingredient: | hydromorphone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 212133
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 212133
Suppliers and Packaging for NDA: 212133
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212133 | ANDA | Camber Pharmaceuticals, Inc. | 31722-119 | 31722-119-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-119-01) |
| HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212133 | ANDA | Camber Pharmaceuticals, Inc. | 31722-120 | 31722-120-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-120-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 8MG | ||||
| Approval Date: | Sep 23, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 12MG | ||||
| Approval Date: | Sep 23, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 16MG | ||||
| Approval Date: | Sep 23, 2020 | TE: | AB | RLD: | No | ||||
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