Details for New Drug Application (NDA): 201750
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NDA 201750 describes ULTACAN FORTE, which is a drug marketed by Hansamed Inc and is included in one NDA. Additional details are available on the ULTACAN FORTE profile page.
The generic ingredient in ULTACAN FORTE is articaine hydrochloride; epinephrine bitartrate. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the articaine hydrochloride; epinephrine bitartrate profile page.
The generic ingredient in ULTACAN FORTE is articaine hydrochloride; epinephrine bitartrate. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the articaine hydrochloride; epinephrine bitartrate profile page.
Summary for 201750
| Tradename: | ULTACAN FORTE |
| Applicant: | Hansamed Inc |
| Ingredient: | articaine hydrochloride; epinephrine bitartrate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) | ||||
| Approval Date: | Jul 11, 2017 | TE: | RLD: | No | |||||
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