Miochol-e
Drug - Miochol-e
The trade name of the product as shown on the labeling.
Dosage -
FOR SOLUTION; OPHTHALMIC
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Acetylcholine Chloride
Multiple ingredients are in alphabetical order.
Strength -
20MG/VIAL
The potency of the active ingredient(s), Acetylcholine Chloride. May repeat for multiple part products.
Applicant -
NOVARTIS
The firm name holding legal responsibility for Miochol-e. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020213
The FDA assigned number to Miochol-e. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Miochol-e. 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 -
Sep 22, 1993
The date Miochol-e 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) -
Yes
The pioneer or innovator of Miochol-e. 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 Miochol-e is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Miochol-e.
Miochol-e
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