Ventolin Rotacaps

   
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Ventolin Rotacaps


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

Dosage - CAPSULE; INHALATION
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 0.2MG BASE
The potency of the active ingredient(s), Albuterol Sulfate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019489
The FDA assigned number to Ventolin Rotacaps. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ventolin Rotacaps. 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 - May 4, 1988
The date Ventolin Rotacaps 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 Ventolin Rotacaps. 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 Ventolin Rotacaps 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 Ventolin Rotacaps.

Ventolin Rotacaps