Loperamide Hcl And Simethicone
Drug - Loperamide Hcl And Simethicone
The trade name of the product as shown on the labeling.
Dosage -
TABLET, CHEWABLE; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Loperamide Hydrochloride; Simethicone
Multiple ingredients are in alphabetical order.
Strength -
2MG;125MG
The potency of the active ingredient(s), Loperamide Hydrochloride; Simethicone. May repeat for multiple part products.
Applicant -
PERRIGO
The firm name holding legal responsibility for Loperamide Hcl And Simethicone. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
076029
The FDA assigned number to Loperamide Hcl And Simethicone. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Loperamide Hcl And Simethicone. 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 -
Aug 30, 2002
The date Loperamide Hcl And Simethicone 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 Loperamide Hcl And Simethicone. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
Type -
OTC
The group or category of approved drugs Loperamide Hcl And Simethicone is in. Format is RX, OTC, DISCN.
Applicant Full Name -
L Perrigo Co
The full name of the firm holding legal responsibility for the new application of Loperamide Hcl And Simethicone.
Loperamide Hcl And Simethicone
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