Infasurf Preservative Free

   
Google
 
Web NewDrugInformation.com

Infasurf Preservative Free


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

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

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

Strength - 35MG/ML
The potency of the active ingredient(s), Calfactant. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020521
The FDA assigned number to Infasurf Preservative Free. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Infasurf 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 - Jul 1, 1998
The date Infasurf 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) - Yes
The pioneer or innovator of Infasurf Preservative Free. 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 Infasurf Preservative Free is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ony Inc
The full name of the firm holding legal responsibility for the new application of Infasurf Preservative Free.

Infasurf Preservative Free