Details for New Drug Application (NDA): 018024
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NDA 018024 describes NUBAIN, which is a drug marketed by Ph Health and is included in one NDA. Additional details are available on the NUBAIN profile page.
The generic ingredient in NUBAIN is nalbuphine hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the nalbuphine hydrochloride profile page.
The generic ingredient in NUBAIN is nalbuphine hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the nalbuphine hydrochloride profile page.
Summary for 018024
| Tradename: | NUBAIN |
| Applicant: | Ph Health |
| Ingredient: | nalbuphine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 018024
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Strength | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Strength | 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | May 27, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Strength | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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