Pseudoephedrine Hcl/chlorpheniramine Maleate
Drug - Pseudoephedrine Hcl/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 -
8MG;120MG
The potency of the active ingredient(s), Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride. May repeat for multiple part products.
Applicant -
GRAHAM DM
The firm name holding legal responsibility for Pseudoephedrine Hcl/chlorpheniramine Maleate. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
018844
The FDA assigned number to Pseudoephedrine Hcl/chlorpheniramine Maleate. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Pseudoephedrine Hcl/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 20, 1985
The date Pseudoephedrine Hcl/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/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/chlorpheniramine Maleate is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Dm Graham Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Pseudoephedrine Hcl/chlorpheniramine Maleate.
Pseudoephedrine Hcl/chlorpheniramine Maleate
Pseudoephedrine Hcl And Chlorpheniramine Maleate 12mg;120mg Capsule, Extended Release; Oral Pseudoephedrine Hcl/chlorpheniramine Maleate 12mg;120mg Capsule, Extended Release; Oral Pseudoephedrine Hcl/chlorpheniramine Maleate 8mg;120mg 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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