Aerolate Iii

   
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Aerolate Iii


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

Dosage - CAPSULE, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 65MG
The potency of the active ingredient(s), Theophylline. May repeat for multiple part products.

Applicant - FLEMING PHARMS
The firm name holding legal responsibility for Aerolate Iii. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 085075
The FDA assigned number to Aerolate Iii. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Aerolate Iii. 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 - Nov 24, 1986
The date Aerolate Iii 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 Aerolate Iii. 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 Aerolate Iii is in. Format is RX, OTC, DISCN.

Applicant Full Name - Fleming And Co Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Aerolate Iii.

Aerolate Iii