Diphenoxylate Hcl And Atropine Sulfate

   
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Diphenoxylate Hcl And Atropine Sulfate


Drug - Diphenoxylate Hcl And Atropine Sulfate
The trade name of the product as shown on the labeling.

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Atropine Sulfate; Diphenoxylate Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 0.025MG;2.5MG
The potency of the active ingredient(s), Atropine Sulfate; Diphenoxylate Hydrochloride. May repeat for multiple part products.

Applicant - WEST WARD
The firm name holding legal responsibility for Diphenoxylate Hcl And Atropine Sulfate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 087765
The FDA assigned number to Diphenoxylate Hcl And Atropine Sulfate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Diphenoxylate Hcl And Atropine Sulfate. 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 - Mar 15, 1982
The date Diphenoxylate Hcl And Atropine Sulfate 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 Diphenoxylate Hcl And Atropine Sulfate. 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 Diphenoxylate Hcl And Atropine Sulfate is in. Format is RX, OTC, DISCN.

Applicant Full Name - West Ward Pharmaceutical Corp
The full name of the firm holding legal responsibility for the new application of Diphenoxylate Hcl And Atropine Sulfate.

Diphenoxylate Hcl And Atropine Sulfate