Novocol Pharmaceutical of Canada, Inc.

FDA Drug Class II Ongoing

Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson De

October 31, 2025 Novocol Pharmaceutical of Canada, Inc. 12,033 cartons units

FDA Drug Class II Ongoing

Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distribute

October 31, 2025 Novocol Pharmaceutical of Canada, Inc.

FDA Drug Class II Ongoing

darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactur

October 31, 2025 Novocol Pharmaceutical of Canada, Inc. 5,520 Cartons units

FDA Drug Class II Ongoing

3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply

October 31, 2025 Novocol Pharmaceutical of Canada, Inc. 5,825 units

FDA Drug Class II Ongoing

2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply

October 31, 2025 Novocol Pharmaceutical of Canada, Inc. 18,789 cartons- 50 cartridges /carton units

FDA Drug Class II Ongoing

OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed b

October 31, 2025 Novocol Pharmaceutical of Canada, Inc. 1,636 cartons units

FDA Drug Class II Ongoing

Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of

October 31, 2025 Novocol Pharmaceutical of Canada, Inc. 40 cartons units

FDA Drug Class III Terminated

Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Manufactured for SEPTODONT, Inc., Louisville, CO 80027, by Nov

November 20, 2020 Novocol Pharmaceutical of Canada, Inc. 15,398 cartridges units