OBJECTIVES: The Office of Generic Drugs (OGD) began publishing bioequivalence (BE) recommendations for specific (complex/non-complex) products in 2007 to support generic drug development. Nevertheless, little is known about patterns of BE recommendations. The purpose of this study was to describe patterns of BE recommendations published by the OGD and trends of abbreviated new drug application (ANDA) approvals over time. METHODS: An analysis of approved ANDAs was conducted at the time of approval from 2007-June 2015(n= 4,028), using data from the publically available product-specific BE guidance website, Drugs@FDA, and National Drug Code (NDC) directory databases. Guidance patterns, trends, and the distribution of ANDAs approved that have BE recommendations compared to those ANDAs approved that did not have BE recommendations were examined using descriptive statistics and chi-squared tests. RESULTS: A total of 1,439 published BE recommendations between 2007-September 2015 were identified. Number of recommendations was highest in 2008(n=316) but the trend was inconsistent (P<0.05). Corticosteroids had the highest proportion of BE recommendations (3.68%), followed by opioid agonists (3.51%), and nonsteroidal anti-inflammatory drugs (3.08%). Compared with BE recommendations, opioid agonists (4.31%), anti-epileptics (4.25%), and angiotensin II receptor blockers (3.43%) were pharmacologic classes with a high proportion of approved ANDAs(P<0.05). Overall, 66.68% of ANDAs approved referenced drug products associated with a BE recommendation and the average ANDA numbers(±SD), excluding solutions/injectables, per recommendation was 2.58(±4.35). An analysis of ANDAs approved over time demonstrated the share of ANDAs approved with recommendations was consistently higher than the share of ANDAs approved without recommendations(P <0.05). CONCLUSIONS: Numbers of published BE recommendations varied over time. BE recommendations cover a wide range of pharmacologic classes and the proportion of ANDAs approved with recommendations was high. Non-complex products may not require recommendations and findings support the continuing need for BE recommendations for more complex products that may further facilitate ANDA approvals.