Propulsid

   
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Propulsid


Drug - Propulsid
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) - Cisapride Monohydrate
Multiple ingredients are in alphabetical order.

Strength - EQ 20MG BASE
The potency of the active ingredient(s), Cisapride Monohydrate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020210
The FDA assigned number to Propulsid. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Propulsid. 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 - Dec 23, 1993
The date Propulsid 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 Propulsid. 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 Propulsid is in. Format is RX, OTC, DISCN.

Applicant Full Name - Janssen Pharmaceutica Products Lp
The full name of the firm holding legal responsibility for the new application of Propulsid.

Propulsid