Synarel
Drug - Synarel
The trade name of the product as shown on the labeling.
Dosage -
SPRAY, METERED; NASAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Nafarelin Acetate
Multiple ingredients are in alphabetical order.
Strength -
EQ 0.2MG BASE/SPRAY
The potency of the active ingredient(s), Nafarelin Acetate. May repeat for multiple part products.
Applicant -
GD SEARLE LLC
The firm name holding legal responsibility for Synarel. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
019886
The FDA assigned number to Synarel. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Synarel. 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 13, 1990
The date Synarel 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 Synarel. 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 Synarel is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Gd Searle Llc
The full name of the firm holding legal responsibility for the new application of Synarel.
Synarel
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