Inflamase Forte

   
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Inflamase Forte


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

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

Active Ingredient(s) - Prednisolone Sodium Phosphate
Multiple ingredients are in alphabetical order.

Strength - EQ 0.9% PHOSPHATE
The potency of the active ingredient(s), Prednisolone Sodium Phosphate. May repeat for multiple part products.

Applicant - NOVARTIS
The firm name holding legal responsibility for Inflamase Forte. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 080751
The FDA assigned number to Inflamase Forte. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Inflamase Forte. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Approved Prior to Jan 1, 1982
The date Inflamase Forte 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 Inflamase Forte. 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 Inflamase Forte is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Inflamase Forte.

Inflamase Forte