Details for New Drug Application (NDA): 005010
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NDA 005010 describes DEMEROL, which is a drug marketed by Hospira and Validus Pharms 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. Three 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. Three suppliers are listed for this compound. Additional details are available on the meperidine hydrochloride profile page.
Summary for 005010
| Tradename: | DEMEROL |
| Applicant: | Validus Pharms |
| Ingredient: | meperidine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 005010
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| 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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