Nitrofurantoin (monohydrate/macrocrystals)


Nitrofurantoin (monohydrate/macrocrystals)

Drug - Nitrofurantoin (monohydrate/macrocrystals)
The trade name of the product as shown on the labeling.

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 - RANBAXY
The firm name holding legal responsibility for Nitrofurantoin (monohydrate/macrocrystals). The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076951
The FDA assigned number to Nitrofurantoin (monohydrate/macrocrystals). Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Nitrofurantoin (monohydrate/macrocrystals). 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 - Mar 30, 2005
The date Nitrofurantoin (monohydrate/macrocrystals) 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 Nitrofurantoin (monohydrate/macrocrystals). 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 Nitrofurantoin (monohydrate/macrocrystals) is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ranbaxy Laboratories Ltd
The full name of the firm holding legal responsibility for the new application of Nitrofurantoin (monohydrate/macrocrystals).

Nitrofurantoin (monohydrate/macrocrystals)