Codimal-l.A. 12

   
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Codimal-l.A. 12


Drug - Codimal-l.A. 12
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 - SCHWARZ PHARMA
The firm name holding legal responsibility for Codimal-l.A. 12. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018935
The FDA assigned number to Codimal-l.A. 12. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Codimal-l.A. 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 - Apr 15, 1985
The date Codimal-l.A. 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 Codimal-l.A. 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 Codimal-l.A. 12 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Schwarz Pharma Inc
The full name of the firm holding legal responsibility for the new application of Codimal-l.A. 12.

Codimal-l.A. 12