Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

Abbreviated Antibiotic Drug

AADA Abbreviated Antibiotic Drug Application (FDA) (used primarily for generics)... [Pg.524]

This guidance provides recommendations to sponsors of new drug applications (NDA s), abbreviated new drug applications (ANDA s), and abbreviated antibiotic applications (AADA s) who intend, during the postapproval period, to change 1) the components or composition 2) the site of manufacture 3) the scale-up/scale-down of manufacture and/or 4) the manufacturing (process and equipment) of an immediate release oral formulation. [Pg.353]

Organization ofan Abbreviated New Drug Application and an Abbreviated Antibiotic Application, March 2,1999. [Pg.64]

Filing an application and an abbreviated antibiotic application and receiving an abbreviated new drug application... [Pg.158]

The FDA generated a guidance document regarding the content and format of an ANDA entitled Guidance for Industry Organization of an Abbreviated New Drug Application and an Abbreviated Antibiotic Application (February, 1999). ... [Pg.216]

Figure 12-7. Proposed sites of inhibition (0) of the respiratory chain by specific drugs, chemicals, and antibiotics. The sites that appear to support phosphorylation are indicated. BAL, dimercaprol. TTFA, an Fe-chelating agent. Complex I, NADHiubiquinone oxidoreductase complex II, succinate ubiquinone oxidoreductase complex III, ubiquinohferricytochrome c oxidoreductase complex IV, ferrocytochrome ctoxygen oxidoreductase. Other abbreviations as in Figure 12-4. Figure 12-7. Proposed sites of inhibition (0) of the respiratory chain by specific drugs, chemicals, and antibiotics. The sites that appear to support phosphorylation are indicated. BAL, dimercaprol. TTFA, an Fe-chelating agent. Complex I, NADHiubiquinone oxidoreductase complex II, succinate ubiquinone oxidoreductase complex III, ubiquinohferricytochrome c oxidoreductase complex IV, ferrocytochrome ctoxygen oxidoreductase. Other abbreviations as in Figure 12-4.
D/C is another example of an abbreviation that should not be used. It has been written to mean either discontinue or discharge, sometimes resulting in premature stoppage of a patient s medications. In Fig. 30-5, the d/c order was incorrectly interpreted as discontinuation of an antibiotic that the patient had never even received. In reality, the d/c is really OK, meaning that the drug was approved for use by the infectious disease physician. [Pg.527]


See other pages where Abbreviated Antibiotic Drug is mentioned: [Pg.29]    [Pg.30]    [Pg.373]    [Pg.469]    [Pg.308]    [Pg.29]    [Pg.30]    [Pg.373]    [Pg.469]    [Pg.308]    [Pg.447]    [Pg.427]    [Pg.278]    [Pg.1780]    [Pg.3188]    [Pg.340]    [Pg.598]    [Pg.142]    [Pg.242]    [Pg.1548]    [Pg.730]   


SEARCH



Antibiotic drug

© 2024 chempedia.info