Betoptic Pilo

   
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Betoptic Pilo


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

Dosage - SUSPENSION/DROPS; OPHTHALMIC
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Betaxolol Hydrochloride; Pilocarpine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 0.25% BASE;1.75%
The potency of the active ingredient(s), Betaxolol Hydrochloride; Pilocarpine Hydrochloride. May repeat for multiple part products.

Applicant - ALCON
The firm name holding legal responsibility for Betoptic Pilo. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020619
The FDA assigned number to Betoptic Pilo. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Betoptic Pilo. 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 17, 1997
The date Betoptic Pilo 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 Betoptic Pilo. 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 Betoptic Pilo is in. Format is RX, OTC, DISCN.

Applicant Full Name - Alcon Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Betoptic Pilo.

Betoptic Pilo