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[ÇóÖú] maximum potencyµÄº¬Òå¼°À´Ô´ ÒÑÓÐ1È˲ÎÓë

Ïò¸÷λ´óÏÀÇóÖú£º¡°Inactive Ingredient Search for Approved Drug ProductsÖÐmaximum potencyµÄº¬Òå¼°À´Ô´¡±
1) The "maximum potency" field specifies the maximum amount of inactive ingredient for each route/dosage form containing that ingredient. (http://www.fda.gov/Drugs/InformationOnDrugs/ucm075230.htm)
"maximum potency"ÊÇָÿƬ£¨½ºÄÒ£©ÖеÄ×î´óÓÃÁ¿£¬»¹ÊÇÿÌì·þÓõÄ×î´óÓÃÁ¿£¿
"maximum potency"Óë¡°PDE£¨ÔÊÐíµÄÈÕ½Ó´¥Á¿£©¡±»òÏ޶ȵȸÅÄîÓÐÇø±ðÂð£¿
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Search Results for: "acetone"

INACTIVE
INGREDIENT ROUTE;DOSAGE FORM; CAS NUMBER; UNII ;MAXIMUM POTENCY;
ACETONE IMPLANTATION; PELLET 67641 1364PS73AF   
ACETONE ORAL; CAPSULE, ENTERIC COATED PELLETS 67641 1364PS73AF 300.504MG  
ACETONE ORAL; GRANULE, FOR SUSPENSION 67641 1364PS73AF   
ACETONE ORAL; TABLET 67641 1364PS73AF   
ACETONE ORAL; TABLET, COATED 67641 1364PS73AF   
ACETONE ORAL; TABLET, DELAYED ACTION 67641 1364PS73AF   
ACETONE ORAL; TABLET, EXTENDED RELEASE 67641 1364PS73AF 460MG  
ACETONE ORAL; TABLET, FOR SUSPENSION 67641 1364PS73AF   
ACETONE ORAL; TABLET, SUSTAINED ACTION 67641 1364PS73AF   
ACETONE ORAL-21; TABLET 67641 1364PS73AF   
ACETONE TOPICAL; LOTION 67641 1364PS73AF 10%  
ACETONE TOPICAL; SHAMPOO 67641 1364PS73AF 13%  
ACETONE TOPICAL; SOLUTION 67641 1364PS73AF 12.69%  
ACETONE SODIUM BISULFITE AN,CNBLK INTRATHECAL; INJECTION 540921 47VY054OXY   
ACETONE SODIUM BISULFITE AN,INFILTRATION; INJECTION 540921 47VY054OXY   
ACETONE SODIUM BISULFITE DENTAL; INJECTION 540921 47VY054OXY   
ACETONE SODIUM BISULFITE INHALATION; SOLUTION 540921 47VY054OXY 0.5003%  
ACETONE SODIUM BISULFITE NERVE BLOCK; INJECTION 540921 47VY054OXY  


ÆäÖУ¬±ûͪµÄ"maximum potency"¿ÉΪ300.504MG£¬»ò460MG»ò10%£¬Ô¶Ô¶¸ßÓÚ¡°»¯Ñ§Ò©ÎïÓлúÈܼÁ²ÐÁôÁ¿Ñо¿¼¼ÊõÖ¸µ¼Ô­Ôò¡±£¨PDE=50.0mg, ÏÞ¶È0.5%£©£»
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Maximum potency is the amount of the excipient used in the approved product that is the basis for the IID listing. The IID lists the highest amount of the excipient per unit dose in each dosage form in which it is used. The amounts shown for maximum potency do not reflect the maximum daily intake (MDI) of the excipient unless the maximum daily dose of the product that is the basis for the listing is only a single unit. For topical products and other products where excipients are expressed as a percentage of the product formula, maximum potency is the highest formula percentage. Maximum potency of an excipient is a dynamic value that changes when FDA approves products with new, higher levels of the excipient. After approval, these new maximum potencies will appear in the next publication of the IID.

ÖØµã£ºThe amounts shown for maximum potency do not reflect the maximum daily intake (MDI) of the excipient unless the maximum daily dose of the product that is the basis for the listing is only a single unit.
2Â¥2020-06-08 11:29:28
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