Codeine, Aspirin, Apap Formula No. 4
Drug - Codeine, Aspirin, Apap Formula No. 4
The trade name of the product as shown on the labeling.
Dosage -
CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Acetaminophen; Aspirin; Codeine Phosphate
Multiple ingredients are in alphabetical order.
Strength -
150MG;180MG;60MG
The potency of the active ingredient(s), Acetaminophen; Aspirin; Codeine Phosphate. May repeat for multiple part products.
Applicant -
SCHERER LABS
The firm name holding legal responsibility for Codeine, Aspirin, Apap Formula No. 4. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
085638
The FDA assigned number to Codeine, Aspirin, Apap Formula No. 4. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Codeine, Aspirin, Apap Formula No. 4. 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 Codeine, Aspirin, Apap Formula No. 4 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 Codeine, Aspirin, Apap Formula No. 4. 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 Codeine, Aspirin, Apap Formula No. 4 is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Scherer Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Codeine, Aspirin, Apap Formula No. 4.
Codeine, Aspirin, Apap Formula No. 4
Tylenol (caplet) 650mg Tablet, Extended Release; Oral Tylenol (geltab) 650mg Tablet, Extended Release; Oral Acetaminophen, Aspirin And Caffeine 250mg;250mg;65mg Tablet; Oral Excedrin (migraine) 250mg;250mg;65mg Tablet; Oral Acetaminophen, Aspirin, And Codeine Phosphate 150mg;180mg;15mg Capsule; Oral Acetaminophen, Aspirin, And Codeine Phosphate 150mg;180mg;30mg Capsule; Oral Acetaminophen, Aspirin, And Codeine Phosphate 150mg;180mg;60mg Capsule; Oral Codeine, Aspirin, Apap Formula No. 2 150mg;180mg;15mg Capsule; Oral Codeine, Aspirin, Apap Formula No. 3 150mg;180mg;30mg Capsule; Oral Codeine, Aspirin, Apap Formula No. 4 150mg;180mg;60mg Capsule; Oral
NewDrugInformation
|
|