Monistat 3 Combination Pack (prefilled)

   
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Monistat 3 Combination Pack (prefilled)


Drug - Monistat 3 Combination Pack (prefilled)
The trade name of the product as shown on the labeling.

Dosage - CREAM; TOPICAL, VAGINAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Miconazole Nitrate
Multiple ingredients are in alphabetical order.

Strength - 2%,4%
The potency of the active ingredient(s), Miconazole Nitrate. May repeat for multiple part products.

Applicant - PERSONAL PRODS
The firm name holding legal responsibility for Monistat 3 Combination Pack (prefilled). The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021261
The FDA assigned number to Monistat 3 Combination Pack (prefilled). Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Monistat 3 Combination Pack (prefilled). 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 - Feb 2, 2001
The date Monistat 3 Combination Pack (prefilled) 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 Monistat 3 Combination Pack (prefilled). 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 Monistat 3 Combination Pack (prefilled) is in. Format is RX, OTC, DISCN.

Applicant Full Name - Personal Products Co
The full name of the firm holding legal responsibility for the new application of Monistat 3 Combination Pack (prefilled).

Monistat 3 Combination Pack (prefilled)