Slo-phyllin
Drug - Slo-phyllin
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) -
Theophylline
Multiple ingredients are in alphabetical order.
Strength -
60MG
The potency of the active ingredient(s), Theophylline. May repeat for multiple part products.
Applicant -
AVENTIS
The firm name holding legal responsibility for Slo-phyllin. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
085206
The FDA assigned number to Slo-phyllin. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Slo-phyllin. 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 24, 1982
The date Slo-phyllin 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 Slo-phyllin. 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 Slo-phyllin is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Aventis Pharmaceutical Products Inc
The full name of the firm holding legal responsibility for the new application of Slo-phyllin.
Slo-phyllin
Slo-phyllin 60mg Capsule, Extended Release; Oral Elixophyllin Sr 250mg Capsule, Extended Release; Oral Slo-bid 100mg Capsule, Extended Release; Oral Slo-bid 125mg Capsule, Extended Release; Oral Slo-bid 200mg Capsule, Extended Release; Oral Slo-bid 300mg Capsule, Extended Release; Oral Slo-bid 50mg Capsule, Extended Release; Oral Slo-bid 75mg Capsule, Extended Release; Oral Slo-phyllin 125mg Capsule, Extended Release; Oral Slo-phyllin 250mg Capsule, Extended Release; Oral
NewDrugInformation
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