Details for New Drug Application (NDA): 021555
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NDA 021555 describes CHLORAPREP TRIPLE SWABSTICK, which is a drug marketed by Becton Dickinson Co and is included in one NDA. It is available from one supplier. Additional details are available on the CHLORAPREP TRIPLE SWABSTICK profile page.
The generic ingredient in CHLORAPREP TRIPLE SWABSTICK 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 TRIPLE SWABSTICK 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 021555
| Tradename: | CHLORAPREP TRIPLE SWABSTICK |
| Applicant: | Becton Dickinson Co |
| Ingredient: | chlorhexidine gluconate; isopropyl alcohol |
| Patents: | 0 |
Pharmacology for NDA: 021555
| Physiological Effect | Decreased Cell Wall Integrity |
Suppliers and Packaging for NDA: 021555
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHLORAPREP ONE-STEP SEPP | chlorhexidine gluconate; isopropyl alcohol | SWAB;TOPICAL | 021555 | 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 SEPP | chlorhexidine gluconate; isopropyl alcohol | SWAB;TOPICAL | 021555 | 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: | SWAB;TOPICAL | Strength | 2%;70% (0.67ML) | ||||
| Approval Date: | Oct 7, 2002 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SWAB;TOPICAL | Strength | 2%;70% (1.75ML) | ||||
| Approval Date: | May 10, 2005 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SWAB;TOPICAL | Strength | 2%;70% (5.25ML) | ||||
| Approval Date: | Jun 10, 2009 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021555
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Becton Dickinson Co | CHLORAPREP ONE-STEP SEPP | chlorhexidine gluconate; isopropyl alcohol | SWAB;TOPICAL | 021555-001 | Oct 7, 2002 | 5,690,958 | ⤷ Subscribe |
| Becton Dickinson Co | CHLORAPREP SINGLE SWABSTICK | chlorhexidine gluconate; isopropyl alcohol | SWAB;TOPICAL | 021555-002 | May 10, 2005 | 5,690,958 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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