Phenylpropanolamine Hcl W/ Chlorpheniramine Maleate

   
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Phenylpropanolamine Hcl W/ Chlorpheniramine Maleate


Drug - Phenylpropanolamine Hcl W/ 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; Phenylpropanolamine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 8MG;75MG
The potency of the active ingredient(s), Chlorpheniramine Maleate; Phenylpropanolamine Hydrochloride. May repeat for multiple part products.

Applicant - CENT PHARMS
The firm name holding legal responsibility for Phenylpropanolamine Hcl W/ Chlorpheniramine Maleate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018809
The FDA assigned number to Phenylpropanolamine Hcl W/ Chlorpheniramine Maleate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Phenylpropanolamine Hcl W/ 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 - May 7, 1984
The date Phenylpropanolamine Hcl W/ 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 Phenylpropanolamine Hcl W/ 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 Phenylpropanolamine Hcl W/ Chlorpheniramine Maleate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Central Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Phenylpropanolamine Hcl W/ Chlorpheniramine Maleate.

Phenylpropanolamine Hcl W/ Chlorpheniramine Maleate