Atropine Sulfate

   
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Atropine Sulfate


Drug - Atropine Sulfate
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) - Atropine Sulfate
Multiple ingredients are in alphabetical order.

Strength - EQ 0.36MG BASE/INH
The potency of the active ingredient(s), Atropine Sulfate. May repeat for multiple part products.

Applicant - US ARMY
The firm name holding legal responsibility for Atropine Sulfate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020056
The FDA assigned number to Atropine Sulfate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Atropine Sulfate. 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 - Sep 19, 1990
The date Atropine Sulfate 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 Atropine Sulfate. 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 Atropine Sulfate is in. Format is RX, OTC, DISCN.

Applicant Full Name - United States Army Office Surgeon General
The full name of the firm holding legal responsibility for the new application of Atropine Sulfate.

Atropine Sulfate