Mucosil-10
Drug - Mucosil-10
The trade name of the product as shown on the labeling.
Dosage -
SOLUTION; INHALATION, ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Acetylcysteine
Multiple ingredients are in alphabetical order.
Strength -
10%
The potency of the active ingredient(s), Acetylcysteine. May repeat for multiple part products.
Applicant -
DEY
The firm name holding legal responsibility for Mucosil-10. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
070575
The FDA assigned number to Mucosil-10. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Mucosil-10. 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 -
Oct 14, 1986
The date Mucosil-10 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 Mucosil-10. 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 Mucosil-10 is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Dey Lp
The full name of the firm holding legal responsibility for the new application of Mucosil-10.
Mucosil-10
Mucomyst 10% Solution; Inhalation, Oral Mucomyst 20% Solution; Inhalation, Oral Mucosil-10 10% Solution; Inhalation, Oral Acetylcysteine 20% Solution; Inhalation, Oral Acetylcysteine 10% Solution; Inhalation, Oral Acetylcysteine 10% Solution; Inhalation, Oral Acetylcysteine 20% Solution; Inhalation, Oral Acetylcysteine 20% Solution; Inhalation, Oral Acetylcysteine 10% Solution; Inhalation, Oral Acetylcysteine 20% Solution; Inhalation, Oral
NewDrugInformation
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