Famotidine Preservative Free

   
Google
 
Web NewDrugInformation.com

Famotidine Preservative Free


Drug - Famotidine Preservative Free
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Famotidine
Multiple ingredients are in alphabetical order.

Strength - 10MG/ML
The potency of the active ingredient(s), Famotidine. May repeat for multiple part products.

Applicant - APOTHECON
The firm name holding legal responsibility for Famotidine Preservative Free. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075708
The FDA assigned number to Famotidine Preservative Free. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Famotidine Preservative Free. 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 16, 2001
The date Famotidine Preservative Free 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 Famotidine Preservative Free. 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 Famotidine Preservative Free is in. Format is RX, OTC, DISCN.

Applicant Full Name - Apothecon Inc Div Bristol Myers Squibb
The full name of the firm holding legal responsibility for the new application of Famotidine Preservative Free.

Famotidine Preservative Free