Synophylate

   
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Synophylate


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

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

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

Strength - EQ 165MG BASE/15ML
The potency of the active ingredient(s), Theophylline Sodium Glycinate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 006333
The FDA assigned number to Synophylate. Format is nnnnnn.

Product Number - 008
The FDA assigned number to identify Synophylate. 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 Synophylate 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 Synophylate. 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 Synophylate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Central Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Synophylate.

Synophylate