Indocin Sr


Indocin Sr

Drug - Indocin Sr
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) - Indomethacin
Multiple ingredients are in alphabetical order.

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

Applicant - MERCK
The firm name holding legal responsibility for Indocin Sr. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018185
The FDA assigned number to Indocin Sr. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Indocin Sr. 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 - Feb 23, 1982
The date Indocin Sr 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 Indocin Sr. 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 Indocin Sr is in. Format is RX, OTC, DISCN.

Applicant Full Name - Merck Research Laboratories Div Merck Co Inc
The full name of the firm holding legal responsibility for the new application of Indocin Sr.

Indocin Sr