Details for New Drug Application (NDA): 086364
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NDA 086364 describes LARYNG-O-JET KIT, which is a drug marketed by Intl Medication and is included in one NDA. It is available from two suppliers. Additional details are available on the LARYNG-O-JET KIT profile page.
The generic ingredient in LARYNG-O-JET KIT is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
The generic ingredient in LARYNG-O-JET KIT is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 086364
| Tradename: | LARYNG-O-JET KIT |
| Applicant: | Intl Medication |
| Ingredient: | lidocaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 086364
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 086364
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LARYNG-O-JET KIT | lidocaine hydrochloride | SOLUTION;TOPICAL | 086364 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1553 | 51662-1553-3 | 25 POUCH in 1 CASE (51662-1553-3) / 1 VIAL in 1 POUCH (51662-1553-2) / 4 mL in 1 VIAL |
| LARYNG-O-JET KIT | lidocaine hydrochloride | SOLUTION;TOPICAL | 086364 | ANDA | International Medication Systems, Limited | 76329-6300 | 76329-6300-5 | 25 VIAL in 1 CARTON (76329-6300-5) / 4 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 4% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | No | ||||
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