Details for New Drug Application (NDA): 215650
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NDA 215650 describes XACIATO, which is a drug marketed by Organon Llc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the XACIATO profile page.
The generic ingredient in XACIATO is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
The generic ingredient in XACIATO is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
Summary for 215650
| Tradename: | XACIATO |
| Applicant: | Organon Llc |
| Ingredient: | clindamycin phosphate |
| Patents: | 2 |
Pharmacology for NDA: 215650
| Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 215650
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XACIATO | clindamycin phosphate | GEL;VAGINAL | 215650 | NDA | Organon LLC | 78206-189 | 78206-189-01 | 1 TUBE in 1 CARTON (78206-189-01) / 8 g in 1 TUBE (78206-189-99) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;VAGINAL | Strength | EQ 2% BASE | ||||
| Approval Date: | Dec 7, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 7, 2029 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Dec 7, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 11,129,896 | Patent Expiration: | Sep 22, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING BACTERIAL VAGINOSIS BY SINGLE DOSE ADMINISTRATION OF A CLINDAMYCIN PHARMACEUTICAL GEL FORMULATION | ||||||||
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