Equipin

   
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Equipin


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

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

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

Strength - 3MG
The potency of the active ingredient(s), Homatropine Methylbromide. May repeat for multiple part products.

Applicant - MISSION PHARMA
The firm name holding legal responsibility for Equipin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 086310
The FDA assigned number to Equipin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Equipin. 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 Equipin 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 Equipin. 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 Equipin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mission Pharmacal Co
The full name of the firm holding legal responsibility for the new application of Equipin.

Equipin