Details for New Drug Application (NDA): 005010
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NDA 005010 describes DEMEROL, which is a drug marketed by Hospira and Quagen and is included in two NDAs. It is available from one supplier. Additional details are available on the DEMEROL profile page.
The generic ingredient in DEMEROL is meperidine hydrochloride. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the meperidine hydrochloride profile page.
The generic ingredient in DEMEROL is meperidine hydrochloride. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the meperidine hydrochloride profile page.
Summary for 005010
| Tradename: | DEMEROL |
| Applicant: | Quagen |
| Ingredient: | meperidine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 005010
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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