Synalgos-dc

   
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Synalgos-dc


Drug - Synalgos-dc
The trade name of the product as shown on the labeling.

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

Active Ingredient(s) - Aspirin; Caffeine; Dihydrocodeine Bitartrate
Multiple ingredients are in alphabetical order.

Strength - 356.4MG;30MG;16MG
The potency of the active ingredient(s), Aspirin; Caffeine; Dihydrocodeine Bitartrate. May repeat for multiple part products.

Applicant - LEITNER PHARMS
The firm name holding legal responsibility for Synalgos-dc. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 011483
The FDA assigned number to Synalgos-dc. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Synalgos-dc. 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 - Sep 6, 1983
The date Synalgos-dc 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 Synalgos-dc. 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 Synalgos-dc is in. Format is RX, OTC, DISCN.

Applicant Full Name - Leitner Pharmaceuticals Llc
The full name of the firm holding legal responsibility for the new application of Synalgos-dc.

Synalgos-dc