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BEECHAM's ANEXSIA-D TAB HYDROCODONE BITARTRATE COMBO

Executive Summary

BEECHAM's ANEXSIA-D TAB HYDROCODONE BITARTRATE COMBO is one of nine products in that class of combo drugs getting close FDA scrutiny. A recent memo from FDA's drug labeling compliance division to the agency's field offices lists 12 hydrocodone combo products without approved ANDAs. The compliance office is asking the field force to visit 12 firms to "document the current marketing status" of those products. "If a firm has received a Regulatory Letter and response is unsatisfactory," the FDA memo says, "obtain a sample of each product listed, for a seizure action." A footnote to the list of hydrocodone bitartrate combos without ANDAs indicates that Beecham has received a regulatory letter about the product and had not submitted a satisfactory response as of March 7. The compliance office noted that some of the firms identified on the list for close attention by the field have submitted ANDAs and/or have petitioned for suitability of an ANDA "but the ANDA's are not as yet approved, nor can we at this time forecast if/or when they will be approved." HYDROCODONE BITARTRATE PRODUCTS TO RECEIVE CLOSE FDA FIELD SCRUTINY Amid Labs, Inc. Dolo-Pap Tab (acetaminophen, hydrocodone bitartrate) Anabolic, Inc. Damason-P Tab (aspirin, caffeine, hydrocodone bitartrate) Beecham Labs Anexsia-D Tab (hydrocodone bitartrate, aspirin, phenacetin, caffeine) Berlex Labs, Inc. Anodynos-DHC Tab (aspirin, hydrocodone bitartrate, acetaminophen, hydrocodone) Caldwell & Bloor Diascaphen Tab (aspirin, hydrocodone bitartrate, salicylamide, caffeine) Central Pharmaceutics, Inc. Di-Gesic Tab (acetaminophen, hydrocodone bitartrate, caffeine, aspirin) Luchem Pharm, Inc. Hycomed Tab (hydrocodone bitartrate, acetaminophen) Mason Pharmaceuticals Damason-P Tab (aspirin, caffeine, hydrocodone bitartrate) Pharmedix Damason-P Tab (aspirin, caffeine, hydrocodone bitartrate) Scripotat, Inc. Damason-P Tab (aspirin, caffeine, hydrocodone bitartrate) Shoals Pharmaceutical Company Hycogesic Tab (hydrocodone bitartrate, acetaminophen, aspirin, caffeine) UAD Labs Lorcet Plus Tab (hydrocodone bitartrate 7.5 mg, acetaminophen 650 mg) Lorpac Tab (aspirin, hydrocodone bitartrate, caffeine, acetaminophen)
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PS009878

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