Macrobid

   
Google
 
Web NewDrugInformation.com

Macrobid


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

Dosage - CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Nitrofurantoin; Nitrofurantoin, Macrocrystalline
Multiple ingredients are in alphabetical order.

Strength - 75MG;25MG
The potency of the active ingredient(s), Nitrofurantoin; Nitrofurantoin, Macrocrystalline. May repeat for multiple part products.

Applicant - PROCTER AND GAMBLE
The firm name holding legal responsibility for Macrobid. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020064
The FDA assigned number to Macrobid. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Macrobid. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Dec 24, 1991
The date Macrobid 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 Macrobid. 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 Macrobid is in. Format is RX, OTC, DISCN.

Applicant Full Name - Procter And Gamble Pharmaceuticals Inc Sub Procter And Gamble Co
The full name of the firm holding legal responsibility for the new application of Macrobid.

Macrobid