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Drug - M-predrol
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) - Methylprednisolone Acetate
Multiple ingredients are in alphabetical order.

Strength - 40MG/ML
The potency of the active ingredient(s), Methylprednisolone Acetate. May repeat for multiple part products.

Applicant - BEL MAR
The firm name holding legal responsibility for M-predrol. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 086666
The FDA assigned number to M-predrol. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify M-predrol. 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 - Approved Prior to Jan 1, 1982
The date M-predrol 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 M-predrol. 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 M-predrol is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bel Mar Laboratories Inc
The full name of the firm holding legal responsibility for the new application of M-predrol.