Lomotil

   
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Lomotil


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

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

Active Ingredient(s) - Atropine Sulfate; Diphenoxylate Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 0.025MG;2.5MG
The potency of the active ingredient(s), Atropine Sulfate; Diphenoxylate Hydrochloride. May repeat for multiple part products.

Applicant - GD SEARLE LLC
The firm name holding legal responsibility for Lomotil. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 012462
The FDA assigned number to Lomotil. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Lomotil. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AA
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Approved Prior to Jan 1, 1982
The date Lomotil 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 Lomotil. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

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

Applicant Full Name - Gd Searle Llc
The full name of the firm holding legal responsibility for the new application of Lomotil.

Lomotil