Cromolyn Sodium

   
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Cromolyn Sodium


Drug - Cromolyn Sodium
The trade name of the product as shown on the labeling.

Dosage - SOLUTION; INHALATION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Cromolyn Sodium
Multiple ingredients are in alphabetical order.

Strength - 10MG/ML
The potency of the active ingredient(s), Cromolyn Sodium. May repeat for multiple part products.

Applicant - RESPIRARE
The firm name holding legal responsibility for Cromolyn Sodium. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076469
The FDA assigned number to Cromolyn Sodium. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Cromolyn Sodium. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AN
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Jun 17, 2005
The date Cromolyn Sodium 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 Cromolyn Sodium. 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 Cromolyn Sodium is in. Format is RX, OTC, DISCN.

Applicant Full Name - Respirare Llc
The full name of the firm holding legal responsibility for the new application of Cromolyn Sodium.

Cromolyn Sodium