Details for New Drug Application (NDA): 020832
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NDA 020832 describes CHLORAPREP WITH TINT, which is a drug marketed by Becton Dickinson Co and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the CHLORAPREP WITH TINT profile page.
The generic ingredient in CHLORAPREP WITH TINT is chlorhexidine gluconate; isopropyl alcohol. There are fifty-eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate; isopropyl alcohol profile page.
The generic ingredient in CHLORAPREP WITH TINT is chlorhexidine gluconate; isopropyl alcohol. There are fifty-eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate; isopropyl alcohol profile page.
Summary for 020832
| Tradename: | CHLORAPREP WITH TINT |
| Applicant: | Becton Dickinson Co |
| Ingredient: | chlorhexidine gluconate; isopropyl alcohol |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 020832
Generic Entry Date for 020832*:
Constraining patent/regulatory exclusivity:
Dosage:
SPONGE;TOPICAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 020832
| Physiological Effect | Decreased Cell Wall Integrity |
Suppliers and Packaging for NDA: 020832
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHLORAPREP ONE-STEP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832 | NDA | CareFusion 213, LLC | 54365-400 | 54365-400-31 | 60 POUCH in 1 CARTON (54365-400-31) / 1 APPLICATOR in 1 POUCH / 1 mL in 1 APPLICATOR |
| CHLORAPREP ONE-STEP | chlorhexidine gluconate; isopropyl alcohol | SPONGE;TOPICAL | 020832 | NDA | CareFusion 213, LLC | 54365-400 | 54365-400-30 | 20 POUCH in 1 CARTON (54365-400-30) / 1 APPLICATOR in 1 POUCH / 1.5 mL in 1 APPLICATOR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SPONGE;TOPICAL | Strength | 2%;70% (3ML) | ||||
| Approval Date: | Jul 14, 2000 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SPONGE;TOPICAL | Strength | 2%;70% (26ML) | ||||
| Approval Date: | May 3, 2005 | TE: | RLD: | Yes | |||||
| Patent: | 7,422,388 | Patent Expiration: | Apr 25, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENT'S SKIN PRIOR TO SURGERY | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SPONGE;TOPICAL | Strength | 2%;70% (1.5ML) | ||||
| Approval Date: | Apr 26, 2002 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020832
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