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Details for New Drug Application (NDA): 020111

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NDA 020111 describes DYNA-HEX, which is a drug marketed by Bajaj Medical Llc and is included in one NDA. It is available from one supplier. Additional details are available on the DYNA-HEX profile page.

The generic ingredient in DYNA-HEX is chlorhexidine gluconate. There are fifty-seven drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate profile page.

Summary for NDA: 020111

Bajaj Medical Llc
chlorhexidine gluconate
Therapeutic Class:Dental and Oral Agents

Suppliers and Packaging for NDA: 020111

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
chlorhexidine gluconate
SOLUTION;TOPICAL 020111 NDA Bajaj Medical, LLC 61037-412 61037-412-01 118 mL in 1 BOTTLE, PLASTIC (61037-412-01)
chlorhexidine gluconate
SOLUTION;TOPICAL 020111 NDA Bajaj Medical, LLC 61037-412 61037-412-02 237 mL in 1 BOTTLE, PLASTIC (61037-412-02)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;TOPICALStrength0.75%
Approval Date:Sep 11, 1997TE:RLD:No

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