Pseudoephedrine Hcl And Chlorpheniramine Maleate
Drug - Pseudoephedrine Hcl And Chlorpheniramine Maleate
The trade name of the product as shown on the labeling.
Dosage -
CAPSULE, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
12MG;120MG
The potency of the active ingredient(s), Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride. May repeat for multiple part products.
Applicant -
KV PHARM
The firm name holding legal responsibility for Pseudoephedrine Hcl And Chlorpheniramine Maleate. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
071455
The FDA assigned number to Pseudoephedrine Hcl And Chlorpheniramine Maleate. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Pseudoephedrine Hcl And Chlorpheniramine Maleate. 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 -
Mar 1, 1989
The date Pseudoephedrine Hcl And Chlorpheniramine Maleate 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 Pseudoephedrine Hcl And Chlorpheniramine Maleate. 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 Pseudoephedrine Hcl And Chlorpheniramine Maleate is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Kv Pharmaceutical Co
The full name of the firm holding legal responsibility for the new application of Pseudoephedrine Hcl And Chlorpheniramine Maleate.
Pseudoephedrine Hcl And Chlorpheniramine Maleate
Pseudoephedrine Hcl And Chlorpheniramine Maleate 12mg;120mg 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 Codimal-l.A. 12 12mg;120mg Capsule, Extended Release; Oral Isoclor 8mg;120mg Capsule, Extended Release; Oral Pseudoephedrine Hcl And Chlorpheniramine Maleate 8mg;120mg Capsule, Extended Release; Oral
NewDrugInformation
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