Slo-bid
Drug - Slo-bid
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 -
50MG
The potency of the active ingredient(s), Theophylline. May repeat for multiple part products.
Applicant -
AVENTIS
The firm name holding legal responsibility for Slo-bid. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
088269
The FDA assigned number to Slo-bid. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Slo-bid. 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 -
Jan 31, 1985
The date Slo-bid 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-bid. 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-bid 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-bid.
Slo-bid
Elixophyllin Sr 125mg 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 Aerolate Iii 65mg Capsule, Extended Release; Oral Aerolate Jr 130mg Capsule, Extended Release; Oral Aerolate Sr 260mg Capsule, Extended Release; Oral
NewDrugInformation
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