Tofranil-pm
Drug - Tofranil-pm
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) -
Imipramine Pamoate
Multiple ingredients are in alphabetical order.
Strength -
EQ 125MG HCL
The potency of the active ingredient(s), Imipramine Pamoate. May repeat for multiple part products.
Applicant -
TYCO HLTHCARE
The firm name holding legal responsibility for Tofranil-pm. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
017090
The FDA assigned number to Tofranil-pm. Format is nnnnnn.
Product Number -
003
The FDA assigned number to identify Tofranil-pm. 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 Tofranil-pm 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 Tofranil-pm. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
Type -
RX
The group or category of approved drugs Tofranil-pm is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Tyco Healthcare Group Lp
The full name of the firm holding legal responsibility for the new application of Tofranil-pm.
Tofranil-pm
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