Miochol
Drug - Miochol
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. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
016211
The FDA assigned number to Miochol. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Miochol. 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 Miochol 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. 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 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.
Miochol
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