Details for New Drug Application (NDA): 080445
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NDA 080445 describes MEPERIDINE HYDROCHLORIDE, which is a drug marketed by Abbott, Baxter Hlthcare, Igi Labs Inc, Intl Medication, Parke Davis, Watson Labs, West-ward Pharms Int, Hikma, Barr, Duramed Pharms Barr, Epic Pharma Llc, Genus, Specgx Llc, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Wyeth Ayerst, Hospira, and Icu Medical Inc, and is included in forty-two NDAs. It is available from three suppliers. Additional details are available on the MEPERIDINE HYDROCHLORIDE profile page.
The generic ingredient in MEPERIDINE HYDROCHLORIDE is meperidine hydrochloride. There are six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the meperidine hydrochloride profile page.
The generic ingredient in MEPERIDINE HYDROCHLORIDE is meperidine hydrochloride. There are six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the meperidine hydrochloride profile page.
Summary for 080445
| Tradename: | MEPERIDINE HYDROCHLORIDE |
| Applicant: | West-ward Pharms Int |
| Ingredient: | meperidine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 080445
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 080445
Suppliers and Packaging for NDA: 080445
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEPERIDINE HYDROCHLORIDE | meperidine hydrochloride | INJECTABLE;INJECTION | 080445 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6052 | 0641-6052-25 | 25 VIAL in 1 CARTON (0641-6052-25) / 1 mL in 1 VIAL (0641-6052-01) |
| MEPERIDINE HYDROCHLORIDE | meperidine hydrochloride | INJECTABLE;INJECTION | 080445 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6053 | 0641-6053-25 | 25 VIAL in 1 CARTON (0641-6053-25) / 1 mL in 1 VIAL (0641-6053-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 75MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
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