Somophyllin-crt
Drug - Somophyllin-crt
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 -
300MG
The potency of the active ingredient(s), Theophylline. May repeat for multiple part products.
Applicant -
GRAHAM DM
The firm name holding legal responsibility for Somophyllin-crt. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
088383
The FDA assigned number to Somophyllin-crt. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Somophyllin-crt. 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 -
Feb 27, 1985
The date Somophyllin-crt 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 Somophyllin-crt. 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 Somophyllin-crt is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Dm Graham Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Somophyllin-crt.
Somophyllin-crt
Slo-phyllin 60mg Capsule, Extended Release; Oral Somophyllin-crt 100mg Capsule, Extended Release; Oral Somophyllin-crt 200mg Capsule, Extended Release; Oral Somophyllin-crt 250mg Capsule, Extended Release; Oral Somophyllin-crt 300mg 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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