Details for New Drug Application (NDA): 016812
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NDA 016812 describes KETALAR, which is a drug marketed by Par Sterile Products and is included in one NDA. It is available from three suppliers. Additional details are available on the KETALAR profile page.
The generic ingredient in KETALAR is ketamine hydrochloride. There are eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ketamine hydrochloride profile page.
The generic ingredient in KETALAR is ketamine hydrochloride. There are eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ketamine hydrochloride profile page.
Summary for 016812
| Tradename: | KETALAR |
| Applicant: | Par Sterile Products |
| Ingredient: | ketamine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 016812
| Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 016812
Suppliers and Packaging for NDA: 016812
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KETALAR | ketamine hydrochloride | INJECTABLE;INJECTION | 016812 | NDA | Henry Schein, Inc | 0404-9880 | 0404-9880-20 | 1 VIAL in 1 BAG (0404-9880-20) / 20 mL in 1 VIAL |
| KETALAR | ketamine hydrochloride | INJECTABLE;INJECTION | 016812 | NDA | Par Pharmaceutical, Inc. | 42023-113 | 42023-113-10 | 10 VIAL in 1 CARTON (42023-113-10) / 20 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG BASE/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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