Meclodium
Drug - Meclodium
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) -
Meclofenamate Sodium
Multiple ingredients are in alphabetical order.
Strength -
EQ 100MG BASE
The potency of the active ingredient(s), Meclofenamate Sodium. May repeat for multiple part products.
Applicant -
QUANTUM PHARMICS
The firm name holding legal responsibility for Meclodium. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
071381
The FDA assigned number to Meclodium. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Meclodium. 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 14, 1987
The date Meclodium 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 Meclodium. 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 Meclodium is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Quantum Pharmics Ltd
The full name of the firm holding legal responsibility for the new application of Meclodium.
Meclodium
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