Triaminic-12
Drug - Triaminic-12
The trade name of the product as shown on the labeling.
Dosage -
TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Chlorpheniramine Maleate; Phenylpropanolamine Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
12MG;75MG
The potency of the active ingredient(s), Chlorpheniramine Maleate; Phenylpropanolamine Hydrochloride. May repeat for multiple part products.
Applicant -
NOVARTIS
The firm name holding legal responsibility for Triaminic-12. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
018115
The FDA assigned number to Triaminic-12. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Triaminic-12. 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 Triaminic-12 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 Triaminic-12. 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 Triaminic-12 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 Triaminic-12.
Triaminic-12
Contac 12 Hour 8mg;75mg Capsule, Extended Release; Oral Drize 12mg;75mg Capsule, Extended Release; Oral Ornade 12mg;75mg Capsule, Extended Release; Oral Phenylpropanolamine Hcl W/ Chlorpheniramine Maleate 8mg;75mg Capsule, Extended Release; Oral Contac 12mg;75mg Tablet, Extended Release; Oral Demazin 4mg;25mg Tablet, Extended Release; Oral Triaminic-12 12mg;75mg Tablet, Extended Release; Oral Chlorpheniramine Maleate And Phenylpropanolamine Hcl 12mg;75mg Capsule, Extended Release; Oral Cold Capsule Iv 12mg;75mg Capsule, Extended Release; Oral Cold Capsule V 8mg;75mg Capsule, Extended Release; Oral
NewDrugInformation
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