Valpin 50

   
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Valpin 50


Drug - Valpin 50
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) - Anisotropine Methylbromide
Multiple ingredients are in alphabetical order.

Strength - 50MG
The potency of the active ingredient(s), Anisotropine Methylbromide. May repeat for multiple part products.

Applicant - ENDO PHARMS
The firm name holding legal responsibility for Valpin 50. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 013428
The FDA assigned number to Valpin 50. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Valpin 50. 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 Valpin 50 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 Valpin 50. 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 Valpin 50 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Endo Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Valpin 50.

Valpin 50