Primatene Mist

   
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Primatene Mist


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

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

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

Strength - 0.2MG/INH
The potency of the active ingredient(s), Epinephrine. May repeat for multiple part products.

Applicant - WYETH CONS
The firm name holding legal responsibility for Primatene Mist. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 016126
The FDA assigned number to Primatene Mist. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Primatene Mist. 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 Primatene Mist 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) - Yes
The pioneer or innovator of Primatene Mist. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

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

Applicant Full Name - Wyeth Consumer Healthcare
The full name of the firm holding legal responsibility for the new application of Primatene Mist.

Primatene Mist