Lipo Gantrisin

   
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Lipo Gantrisin


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

Dosage - EMULSION; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Sulfisoxazole Acetyl
Multiple ingredients are in alphabetical order.

Strength - EQ 1GM BASE/5ML
The potency of the active ingredient(s), Sulfisoxazole Acetyl. May repeat for multiple part products.

Applicant - ROCHE
The firm name holding legal responsibility for Lipo Gantrisin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 009182
The FDA assigned number to Lipo Gantrisin. Format is nnnnnn.

Product Number - 009
The FDA assigned number to identify Lipo Gantrisin. 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 Lipo Gantrisin 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 Lipo Gantrisin. 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 Lipo Gantrisin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Hoffmann La Roche Inc
The full name of the firm holding legal responsibility for the new application of Lipo Gantrisin.

Lipo Gantrisin