Salagen

   
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Salagen


Drug - Salagen
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) - Pilocarpine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 7.5MG
The potency of the active ingredient(s), Pilocarpine Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020237
The FDA assigned number to Salagen. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Salagen. 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 - Apr 18, 2003
The date Salagen 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 Salagen. 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 Salagen is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mgi Pharma Inc
The full name of the firm holding legal responsibility for the new application of Salagen.

Salagen