Loperamide Hcl

   
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Loperamide Hcl


Drug - Loperamide Hcl
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) - Loperamide Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 2MG
The potency of the active ingredient(s), Loperamide Hydrochloride. May repeat for multiple part products.

Applicant - ABLE
The firm name holding legal responsibility for Loperamide Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 073528
The FDA assigned number to Loperamide Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Loperamide Hcl. 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 30, 1993
The date Loperamide Hcl 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 Loperamide Hcl. 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 Loperamide Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Able Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Loperamide Hcl.

Loperamide Hcl