Aerosporin

   
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Aerosporin


Drug - Aerosporin
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Polymyxin B Sulfate
Multiple ingredients are in alphabetical order.

Strength - EQ 500,000 U BASE/VIAL
The potency of the active ingredient(s), Polymyxin B Sulfate. May repeat for multiple part products.

Applicant - GLAXOSMITHKLINE
The firm name holding legal responsibility for Aerosporin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 062036
The FDA assigned number to Aerosporin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Aerosporin. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Approved Prior to Jan 1, 1982
The date Aerosporin was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - No
The pioneer or innovator of Aerosporin. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Aerosporin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Glaxosmithkline
The full name of the firm holding legal responsibility for the new application of Aerosporin.

Aerosporin


Golytely 236gm/bot;2.97gm/bot;6.74gm/bot;5.86gm/bot;22.74gm/bot For Solution; Oral
Co-lav 240gm/bot;2.98gm/bot;6.72gm/bot;5.84gm/bot;22.72gm/bot For Suspension; Oral
Colovage 227.1gm/packet;2.82gm/packet;6.36gm/packet;5.53gm/packet;21.5gm/packet For Suspension; Oral
E-z-em Prep Lyte 236gm/bot;2.97gm/bot;6.74gm/bot;5.86gm/bot;22.74gm/bot For Suspension; Oral
Glycoprep 236gm/bot;2.97gm/bot;6.74gm/bot;5.86gm/bot;22.74gm/bot For Suspension; Oral
Go-evac 236gm/bot;2.97gm/bot;6.74gm/bot;5.86gm/bot;22.74gm/bot For Suspension; Oral
Peg-lyte 236gm/bot;2.97gm/bot;6.74gm/bot;5.86gm/bot;22.74gm/bot For Suspension; Oral
Aerosporin Eq 500,000 U Base/vial Injectable; Injection
Colyte-flavored 240gm/bot;2.98gm/bot;6.72gm/bot;5.84gm/bot;22.72gm/bot For Solution; Oral
Golytely 227.1gm/packet;2.82gm/packet;6.36gm/packet;5.53gm/packet;21.5gm/packet For Solution; Oral

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